A Phase 4 interventional study of Recombinant human growth hormone in Growth Hormone Deficiency and Traumatic Brain Injury, sponsored by The University of Texas Medical Branch, Galveston. Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-06-29.
Sponsored by The University of Texas Medical Branch, Galveston · Phase 4, Interventional, and Treatment
Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).
This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 15 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
recombinant human growth hormone (rhGH) self administered daily for one year
Drug: Recombinant human growth hormone
200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)
Also known as: Genotropin, Somatropin, hGH
Maximum Oxygen Uptake at Baseline.
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time frame: baseline
Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time frame: one year
Minute Ventilation at Baseline.
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time frame: baseline
Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time frame: one year
Respiratory Exchange Ratio at Baseline.
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time frame: baseline
Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time frame: one year
Oxygen Pulse at Baseline.
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Time frame: baseline
Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Time frame: one year
Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time frame: baseline
Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time frame: One year
Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time frame: baseline
Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time frame: One year
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time frame: baseline
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time frame: one year
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time frame: baseline
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time frame: one year
Neuropsychological Function as Measured by Digit Span Total at Baseline
Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
Time frame: baseline
Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.
Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
Time frame: one year
Neuropsychological Function as Measured by Processing Speed Index at Baseline
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output. This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded. Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
Time frame: baseline
Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output. This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded. Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
Time frame: one year
Neuropsychological Function as Measured by Letter Fluency at Baseline
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Time frame: baseline
Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Time frame: one year
Depression as Measured by the Beck Depression Inventory at Baseline.
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
Time frame: baseline
Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
Time frame: one year
Fatigue as Measured Using Fatigue Severity Scale at Baseline.
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Time frame: baseline
Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Time frame: one year
Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Maximum torque production during isometric contraction of the knee extensor muscles.
Time frame: baseline
Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Maximum torque production during isometric contraction of the knee extensor muscles.
Time frame: one year
Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time frame: baseline
Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time frame: one year
Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Time frame: baseline
Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Time frame: one year
Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Time frame: baseline
Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time frame: one year
Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time frame: baseline
Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time frame: one year
Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Time frame: baseline
Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Time frame: one year
Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time frame: baseline
Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time frame: one year
Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Maximum torque production during isometric contraction of the knee extensor muscles.
Time frame: baseline
Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Maximum torque production during isometric contraction of the knee extensor muscles.
Time frame: one year
Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time frame: baseline
Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time frame: one year
Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Time frame: baseline
Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Time frame: one year
Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Time frame: baseline
Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time frame: one year
Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Time frame: baseline
Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time frame: one year
Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Time frame: baseline
Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Time frame: one year
Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time frame: baseline
Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time frame: one year
Subjects with a history of mild to severe traumatic brain injury were recruited from 2010 to 2014. Subjects were screened for abnormal growth hormone secretion by glucagon stimulation test. 19 subjects were screened for this study. 15 of the subjects met final inclusion/exclusion criteria and began the treatment phase.
| Milestone | Human Growth Hormone |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
| mL/kg/min | Human Growth Hormone |
|---|---|
| Maximum Oxygen Uptake at Baseline. | 29.0 ± 7.2 |
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
| mL/kg/min | Human Growth Hormone |
|---|---|
| Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy. | 32.1 ± 7.4 |
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
| L/minute | Human Growth Hormone |
|---|---|
| Minute Ventilation at Baseline. | 90.4 ± 24.2 |
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
| L/minute | Human Growth Hormone |
|---|---|
| Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy. | 102.4 ± 23.1 |
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
| ratio of CO2/O2 | Human Growth Hormone |
|---|---|
| Respiratory Exchange Ratio at Baseline. | 1.27 ± 0.12 |
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
| ratio of CO2/O2 | Human Growth Hormone |
|---|---|
| Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy. | 1.27 ± 0.10 |
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
| mL/beat | Human Growth Hormone |
|---|---|
| Oxygen Pulse at Baseline. | 15.2 ± 4.1 |
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
| mL/beat | Human Growth Hormone |
|---|---|
| Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy. | 16.4 ± 4.2 |
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline. | 45.7 ± 10.8 |
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy. | 51.0 ± 9.4 |
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline. | 9.9 ± 3.8 |
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy. | 11.2 ± 2.6 |
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline | 18.7 ± 5.7 |
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy. | 22.7 ± 5.1 |
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline | 7.2 ± 2.9 |
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy | 9.1 ± 2.2 |
Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Digit Span Total at Baseline | 16.0 ± 4.5 |
Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy. | 17.0 ± 3.9 |
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output. This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded. Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Processing Speed Index at Baseline | 102.3 ± 14.9 |
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output. This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded. Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy. | 106.6 ± 15.0 |
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Letter Fluency at Baseline | 38.5 ± 14.5 |
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
| scores on a scale | Human Growth Hormone |
|---|---|
| Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy | 35.4 ± 13.0 |
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
| scores on a scale | Human Growth Hormone |
|---|---|
| Depression as Measured by the Beck Depression Inventory at Baseline. | 13.8 ± 9.7 |
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
| scores on a scale | Human Growth Hormone |
|---|---|
| Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy. | 6.2 ± 6.9 |
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
| scores on a scale | Human Growth Hormone |
|---|---|
| Fatigue as Measured Using Fatigue Severity Scale at Baseline. | 44.3 ± 13.5 |
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
| scores on a scale | Human Growth Hormone |
|---|---|
| Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy. | 34.0 ± 12.5 |
Maximum torque production during isometric contraction of the knee extensor muscles.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline. | 206.0 ± 32.41 |
Maximum torque production during isometric contraction of the knee extensor muscles.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. | 209.6 ± 37.65 |
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline. | 175.2 ± 36.61 |
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. | 182.6 ± 45.29 |
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
| Percent of Maximum Torque | Human Growth Hormone |
|---|---|
| Muscle Fatigue as Measured by Biodex Pro 4 at Baseline. | 35.1 ± 6.30 |
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
| Percent of Maximum Torque | Human Growth Hormone |
|---|---|
| Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. | 36.9 ± 9.89 |
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
| kilograms | Human Growth Hormone |
|---|---|
| Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. | 96.04 ± 18.38 |
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
| kilograms | Human Growth Hormone |
|---|---|
| Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. | 96.55 ± 19.67 |
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
| kilograms | Human Growth Hormone |
|---|---|
| Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline | 61.68 ± 7.55 |
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
| kilograms | Human Growth Hormone |
|---|---|
| Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. | 63.70 ± 8.14 |
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
| kilograms | Human Growth Hormone |
|---|---|
| Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. | 31.19 ± 13.75 |
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
| kilogram | Human Growth Hormone |
|---|---|
| Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. | 29.67 ± 14.30 |
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
| percent of body fat | Human Growth Hormone |
|---|---|
| Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. | 32.47 ± 8.47 |
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
| percent of body fat | Human Growth Hormone |
|---|---|
| Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. | 30.5 ± 9.40 |
Maximum torque production during isometric contraction of the knee extensor muscles.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline. | 131.5 ± 26.38 |
Maximum torque production during isometric contraction of the knee extensor muscles.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy | 130.7 ± 34.77 |
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline | 103.9 ± 12.56 |
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
| Newton-Meters | Human Growth Hormone |
|---|---|
| Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy | 99.6 ± 17.58 |
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
| units on a scale | Human Growth Hormone |
|---|---|
| Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline. | 3.78 ± 1.75 |
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
| units on a scale | Human Growth Hormone |
|---|---|
| Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy. | 3.17 ± 1.54 |
| kilograms | Human Growth Hormone |
|---|---|
| Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. | 75.64 ± 10.80 |
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
| kilograms | Human Growth Hormone |
|---|---|
| Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy | 76.54 ± 10.57 |
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
| kilograms | Human Growth Hormone |
|---|---|
| Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline | 43.84 ± 1.42 |
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
| kilograms | Human Growth Hormone |
|---|---|
| Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. | 44.92 ± 3.47 |
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
| kilograms | Human Growth Hormone |
|---|---|
| Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. | 29.31 ± 9.86 |
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
| kilograms | Human Growth Hormone |
|---|---|
| Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy | 29.15 ± 8.74 |
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
| percent of body fat | Human Growth Hormone |
|---|---|
| Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. | 38.92 ± 8.17 |
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
| percent of body fat | Human Growth Hormone |
|---|---|
| Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. | 38.74 ± 6.84 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Growth Hormone | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
15 subjects with a history of mild to severe traumatic brain injury and abnormal growth hormone secretion were enrolled in this trial.
| Age, Categorical(Participants) | Human Growth Hormone |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | Human Growth Hormone |
|---|---|
| Mean | 45.5 ± 11.2 |
| Sex: Female, Male(Participants) | Human Growth Hormone |
|---|---|
| Female | 5 |
| Male | 10 |
| Region of Enrollment(Participants) | Human Growth Hormone |
|---|---|
| United States | 15 |
| Age at time of injury(years) | Human Growth Hormone |
|---|---|
| Mean | 34.3 ± 15.7 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Medical Branch, Galveston