An interventional study of Percutaneous epidural electrical spinal stimulation and Transcutaneous electrical spinal stimulation in Paraplegia, Tetraplegia and Paralysis, sponsored by Kristin Zhao, PhD. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Kristin Zhao, PhD · Not applicable, Interventional, and Basic science
A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.
The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.
151 studies on the registry are indexed under Paraplegia; 36 are open to participants now.
This study's enrollment of 6 is below the median of 18 across 115 interventional studies indexed under Paraplegia.
Browse Paraplegia studies →Kristin Zhao, PhD is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Device: Percutaneous epidural electrical spinal stimulation
Transcutaneous spinal stimulation will be delivered via skin surface-level electrodes during rehabilitation. The effects of transcutaneous stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Device: Transcutaneous electrical spinal stimulation
Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System
Digitimer DS8R Bipolar Constant Current Stimulator
Electromyography
Change in voltage measurements in major muscle groups below the level of injury. Specifically, change in soleus root mean square voltage during standing with and without stimulation.
Time frame: Through study completion; an average of 5 months.
Foot Pressure
Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.
Time frame: Beginning of intervention to end of intervention, an average of 17 days.
Somatosensory Evoked Potentials
Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Transcranial Magnetic Stimulation Motor Evoked Potentials
Measurement of the threshold percentage change in voltage between pre-intervention and post-intervention in the first trapezius or deltoid muscle activated.
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury
Change sensory and motor function impairment using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete SCI) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Summed results produce overall sensory and motor scores and combine with evaluation of anal sensory and motor function in determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of deep anal pressure and voluntary anal contraction are assessed as a yes/no; absence of these, in addition to sensory scores of 0 at S4-5 indicate a Complete injury (otherwise, the injury is Incomplete).
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Patient-reported Bowel Function
Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Patient-reported Bladder Function
Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Male Patient-reported Sexual Function (1)
Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Male Patient-reported Sexual Function (2)
Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Female Patient-reported Sexual Function
Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Spasticity
Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Neurostimulation User Experience
Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item. Subscales grouping terms into like categories average scores into a 7 point range from -3 to +3, with negative averages associated with negative perceptions, and positive averages associated with positive perceptions.
Time frame: End of intervention, an average of 4 weeks
Overground Ambulation [as Appropriate to the Subject]
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
Time frame: Baseline, 4 Weeks, 8 Weeks, and 20 Weeks
Trunk Stability
Changes in trunk stability based on stable forward reach measured in centimeters, with a greater distance of forward reach characterizing greater trunk stability. Specifically, change in forward reach at the end of the study when comparing stimulation assisted reach and non-stimulation assisted reach.
Time frame: Beginning of intervention to end of intervention, an average of 17 days, 8 weeks post beginning of intervention, 20 weeks post beginning of intervention; change from beginning of intervention at week 20 reported.
Neurostimulator Lead Location and Migration [Epidural Group Only]
Evaluation of current array location via CT.
Time frame: Pre-intervention and 4 weeks post-intervention
Bladder Function Testing
Change in measurements of bladder function (end fill detrusor value) utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography.
Time frame: Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.
Recruitment was conducted from March 4, 2022 to October 11, 2022 within a medical clinic.
| Milestone | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 2 |
| Not completed | 0 | 1 |
| Withdrew: Lengthy covid-19 infection interrupted intervention to an unsatisfactory degree. | 0 | 1 |
Change in voltage measurements in major muscle groups below the level of injury. Specifically, change in soleus root mean square voltage during standing with and without stimulation.
| volts | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Electromyography | 0.00017507 ± 0.04279603 | 0.00006740 ± 0.05917040 |
Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.
| percentage of loading force increase | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Beginning of intervention | 6 ± 9 | 0 ± 0 |
| End of intervention | 40 ± 34 | 0 ± 0 |
Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.
| microvolts | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Left sided measurements | 0.67 ± 0.6 | 0.8 ± 0.99 |
| Right sided measurements | 0.33 ± 0.12 | 0.35 ± 0.07 |
Measurement of the threshold percentage change in voltage between pre-intervention and post-intervention in the first trapezius or deltoid muscle activated.
| percent change | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Transcranial Magnetic Stimulation Motor Evoked Potentials | 3.33 ± 5.77 | 5 ± 7.07 |
Change sensory and motor function impairment using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete SCI) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Summed results produce overall sensory and motor scores and combine with evaluation of anal sensory and motor function in determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of deep anal pressure and voluntary anal contraction are assessed as a yes/no; absence of these, in addition to sensory scores of 0 at S4-5 indicate a Complete injury (otherwise, the injury is Incomplete).
| Participants | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Change between Complete (C) and Incomplete (I) designations | 0 | 0 |
| Change in ASIA Impairment Scale (AIS) rating | 0 | 0 |
| Change in sensation of Deep Anal Pressure (DAP) | 0 | 0 |
| Change in Voluntary Anal Contraction (VAC) | 0 | 0 |
Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.
| Score on a scale | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Patient-reported Bowel Function | -4 (-6 to -2) | -3.5 (-12 to 5) |
Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).
| Score on a scale | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Patient-reported Bladder Function | -11.3 (-12 to -8) | -4.5 (-6 to -3) |
Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.
| Score on a scale | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Male Patient-reported Sexual Function (1) | -6.3 (-14 to 2) | 0 (-1 to 1) |
Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.
| Score on a scale | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Male Patient-reported Sexual Function (2) | -23.3 (-35 to -11) | -1.5 (-2 to -1) |
Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.
No measurements were reported for this outcome.
Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.
| Score on a scale | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Spasticity | 0.057 (-0.033 to 0.090) | 0.088 (-0.207 to 0.383) |
Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item. Subscales grouping terms into like categories average scores into a 7 point range from -3 to +3, with negative averages associated with negative perceptions, and positive averages associated with positive perceptions.
| Score on a scale | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Attractiveness | 3 ± 0 | 2.5 ± 0 |
| Perspicuity | 1.5 ± 0.707 | 1.917 ± 0.382 |
| Efficiency | 2.583 ± 0.382 | 2 ± 0.354 |
| Dependability | 2.083 ± 0.520 | 1.75 ± 0.354 |
| Stimulation | 2.917 ± 0.144 | 2 ± 0.354 |
| Novelty | 2.583 ± 0.382 | 1.75 ± 1.414 |
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
| meters | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Pre-intervention to post-intervention | 9.2 | — |
| Pre-intervention to 8 weeks post intervention | 16.5 | — |
| Pre-intervention to 20 weeks post intervention | 16.5 | — |
Changes in trunk stability based on stable forward reach measured in centimeters, with a greater distance of forward reach characterizing greater trunk stability. Specifically, change in forward reach at the end of the study when comparing stimulation assisted reach and non-stimulation assisted reach.
| centimeters | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Non-stimulation assisted reach | 14.933333 ± 9.3972809 | 3 ± 3 |
| Stimulation assisted reach | 34.933333 ± 14.115319 | 21.5 ± 11 |
Evaluation of current array location via CT.
| millimeters | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Neurostimulator Lead Location and Migration [Epidural Group Only] | -5.35862 (-8.48728 to -2.48357) | — |
Change in measurements of bladder function (end fill detrusor value) utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography.
| cm H2O | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Pre-intervention | 21 ± 15.769168 | 10.5 ± 5.5 |
| Post-intervention | 54.666667 ± 32.148959 | 15 ± 15 |
Collected over Adverse events were assessed over the course of approximately 20 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Percutaneous Epidural Stimulation | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Transcutaneous Epidural Stimulation | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| NephrolithiasisRenal and urinary disorders | 0/3 | 1/3 |
| Event | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation |
|---|---|---|
| Urinary tract infectionRenal and urinary disorders | 1/3 | 2/3 |
| Orthostatic hypotensionVascular disorders | 0/3 | 2/3 |
| Bowel incontinenceGastrointestinal disorders | 0/3 | 2/3 |
| PetechiaeSkin and subcutaneous tissue disorders | 1/3 | 0/3 |
| Urinary incontinenceRenal and urinary disorders | 1/3 | 0/3 |
| Serosanguinous drainageSkin and subcutaneous tissue disorders | 1/3 | 0/3 |
| Urethral irritation post urodynamics studyRenal and urinary disorders | 0/3 | 1/3 |
| HeadacheNervous system disorders | 0/3 | 1/3 |
| Low back painMusculoskeletal and connective tissue disorders | 0/3 | 1/3 |
| PresyncopeNervous system disorders | 0/3 | 1/3 |
| Age, Customized(Participants) | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation | Total |
|---|---|---|---|
| 22-29 | 2 | 2 | 4 |
| 30-39 | 0 | 1 | 1 |
| 40-49 | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 3 | 3 | 6 |
| Race/Ethnicity, Customized(Participants) | Percutaneous Epidural Stimulation | Transcutaneous Epidural Stimulation | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 3 | 6 |
| White | 2 | 3 | 5 |
| Black or African American | 0 | 0 | 0 |
| Multiracial | 0 | 0 | 0 |
| Other | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2022 to primary completion in Mar 2023, 12 months.
Results were first posted in Jul 2024, 1 year 3 months after primary completion.
Of 44 non-industry interventional studies with no phase under Paraplegia, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 131. This study's 12 months is below that.
Counting every sponsor, half of 60 studies reached it within 37 months; a quarter within 12 and three quarters within 131.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Kristin Zhao, PhD