A Phase 2 interventional study of Growth Hormone and Placebo in TBI (Traumatic Brain Injury), Concussion, Brain and Sport Injury, sponsored by Center for Neurological Studies. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Center for Neurological Studies · Phase 2, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).
GHD is the most common anterior pituitary abnormality after traumatic brain injury (TBI). It can occur as a result of either direct pituitary or indirect hypothalamic injury. Sports-related repetitive head trauma might induce pituitary dysfunction, and in particular, isolated GHD. Growth hormone replacement therapy (GHRT) has long been known to have a beneficial effect on body composition and exercise capacity. However, it has recently been shown that GHRT also benefits the brain. The primary objective of the current study is to assess the effect of GH on memory, executive function and attention domains of cognitive function in GHD- professional football players with TBI. The study will also utilize the adult growth hormone deficiency assessment (AGHDA) questionnaire, quantitative electroencephalogram (QEEG) and magnetic resonance imaging (MRI) techniques, respectively, to measure the quality of life (QoL), electrical activity and structural changes in the brain that may correspond to cognitive deficits.
637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.
This study's planned enrollment of 42 is below the median of 63 across 446 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →This is the only study on the registry with Center for Neurological Studies as lead sponsor.
Compared within Brain Concussion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Injuries, Traumatic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
Biological: Growth Hormone
Saline-placebo via auto-injector pens (Haselmeier Inc).
Other: Placebo
Daily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase
Also known as: Norditropin® (somatropin [rDNA origin] injection)
Daily self-injections by subjects: 1-year double-blind phase
Cognitive functions- Working Memory
To assess change in working memory from base line to 1 yr post-treatment. Working memory will be reported as an index score based on scaled scores for the digit span subtest and symbol span subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning.
Time frame: From baseline to 1-year post-treatment
Cognitive functions- Processing Speed
To assess change in Processing Speed from baseline to 1 yr post-treatment. Processing speed will be reported as an index score based on scaled scores of digit symbol subtest and symbol search subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning. Trail Making Test A will also be used to assess processing speed. Reported as T-score. Higher scores reflect better performance.
Time frame: From baseline to 1-year post-treatment
Cognitive functions- Executive Function.
To assess change in Executive Function from baseline to 1 yr post-treatment. Trail Making Test B and verbal fluency (letter and category) will be used to assess executive function. Reported as T-score. T scores have a mean of 50 and a standard deviation of 10. Scores range from 13 to 87. Higher scores reflect better performance.
Time frame: From baseline to 1-year post-treatment
Cognitive functions- Verbal learning and memory
To assess change in Verbal learning and memory from baseline to 1 yr post-treatment. California verbal learning test will be used to assess this outcome measure. Reported as a standard score with a mean of 0 and a standard deviation of 1. Scores range from -0.5 to +5.0. Higher scores reflect better performance.
Time frame: From baseline to 1-year post-treatment
Cognitive functions- ANAM ( Automated Psychological Assessment Metrics)
To assess change in ANAM from baseline to 1 yr post-treatment. ANAM Test System- Core Battery will be used to assess this outcome measure. Reported as a standard score
Time frame: From baseline to 1-year post-treatment
Quality of Life Assessment of Growth Hormone Deficiency in Adults
This measure includes a scale: It is based on the Adult Growth Hormone Deficiency Assessment (AGHDA) QoL questionnaire. It consists of 25 yes/no questions. Score ranges from 0-25 with number of "yes" responses indicating score. A score of 8 or higher is typical of untreated adult GH deficiency. Treatment, on an average, results in a decrease of 2.5 to 3 points on the scale at one year
Time frame: One year (from baseline to 1-year post-treatment)
Change in QEEG Markers- power spectra
Spectral markers include delta (1-5-2.5 Hz), theta (3.5-7.5 Hz), alpha (7.5-12.5 Hz), alpha 1 (7.5-10.0 Hz), alpha 2 (10.0-12.5 Hz), beta 1 (12.5- 25.0 Hz) , beta 2 (25.0-35.0 Hz), gamma (35.0- 50.0 Hz). The power will be averaged over all electrode sites as absolute and relative power.
Time frame: One year (from baseline to 1-year post-treatment)
Change in QEEG Markers- Connectivity Measures
Connectivity measures will include Pearson product moment correlation for the time series and coherence, phase synchronization and phase lag.
Time frame: One year (from baseline to 1-year post-treatment)
MRI
To assess changes in volumetric MRI measurements and diffusion tensor imaging (DTI) measurements
Time frame: One year (from baseline to 1-year post-treatment)
Change in Physical function- Peak O2 consumption (Vo2 max)
Measured in units of liters per minute.
Time frame: One year (from baseline to 1-year post-treatment)
Change in Physical function- Maximum grip strength
Measured in pounds using the CAMRY Digital Hand Dynamometer
Time frame: One year (from baseline to 1-year post-treatment)
Change in Physical function- Isokinetic knee extension peak torque
Measured using the Cybex II isokinetic dynamometer. The maximum torque is recorded in ft-lbs of force
Time frame: One year (from baseline to 1-year post-treatment)
Change in Physical function-DEXA measure
Percent body fat and lean mass by limb and trunk
Time frame: One year (from baseline to 1-year post-treatment)
Adverse events
To assess the incidence and severity of adverse events
Time frame: One year (from baseline to 1-year post-treatment)
MR imaging analysis of hypothalamus and pituitary
for diagnosis of GHD or multiple anterior pituitary hormone deficiencies in GHD - professional football players with TBI
Time frame: One year (from baseline to 1-year post-treatment)
Plan to share: No
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Studies of the drug tested here: Growth Hormone