Trial Outcomes & Findings for Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI (NCT NCT05095454)

NCT ID: NCT05095454

Last Updated: 2024-07-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: Through study completion; an average of 5 months.
• Results posted on: 2024-07-09

Participant Flow

Recruitment was conducted from March 4, 2022 to October 11, 2022 within a medical clinic.

Participant milestones

Measure	Percutaneous Epidural Stimulation 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Overall Study STARTED	3	3
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Percutaneous Epidural Stimulation 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Overall Study Lengthy COVID-19 infection interrupted intervention to an unsatisfactory degree.	0	1

Baseline Characteristics

Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI

Baseline characteristics by cohort

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=3 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator	Total n=6 Participants Total of all reporting groups
Age, Customized 22-29	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized 30-39	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 40-49	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion; an average of 5 months.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=3 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Electromyography	0.00017507 volts Standard Deviation 0.04279603	0.00006740 volts Standard Deviation 0.05917040

PRIMARY outcome

Timeframe: Beginning of intervention to end of intervention, an average of 17 days.

Population: Increase in the difference in total loading force when standing, between beginning and end of intervention (an average of 17 days), with and without stimulation

Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=1 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Foot Pressure Beginning of intervention	6 percentage of loading force increase Standard Deviation 9	0 percentage of loading force increase Standard Deviation 0
Foot Pressure End of intervention	40 percentage of loading force increase Standard Deviation 34	0 percentage of loading force increase Standard Deviation 0

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Population: Change in amplitude of lumbar SSEP during tibial stimulation

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Somatosensory Evoked Potentials Left sided measurements	0.67 microvolts Standard Deviation 0.6	0.8 microvolts Standard Deviation 0.99
Somatosensory Evoked Potentials Right sided measurements	0.33 microvolts Standard Deviation 0.12	0.35 microvolts Standard Deviation 0.07

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Measurement of the threshold percentage change in voltage between pre-intervention and post-intervention in the first trapezius or deltoid muscle activated.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Transcranial Magnetic Stimulation Motor Evoked Potentials	3.33 percent change Standard Deviation 5.77	5 percent change Standard Deviation 7.07

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

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).

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury Change between Complete (C) and Incomplete (I) designations	0 Participants	0 Participants
Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury Change in ASIA Impairment Scale (AIS) rating	0 Participants	0 Participants
Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury Change in sensation of Deep Anal Pressure (DAP)	0 Participants	0 Participants
Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury Change in Voluntary Anal Contraction (VAC)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Patient-reported Bowel Function	-4 Score on a scale Interval -6.0 to -2.0	-3.5 Score on a scale Interval -12.0 to 5.0

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

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).

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Patient-reported Bladder Function	-11.3 Score on a scale Interval -12.0 to -8.0	-4.5 Score on a scale Interval -6.0 to -3.0

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Male Patient-reported Sexual Function (1)	-6.3 Score on a scale Interval -14.0 to 2.0	0 Score on a scale Interval -1.0 to 1.0

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Male Patient-reported Sexual Function (2)	-23.3 Score on a scale Interval -35.0 to -11.0	-1.5 Score on a scale Interval -2.0 to -1.0

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Population: No female participants were enrolled.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Spasticity	0.057 Score on a scale Interval -0.033 to 0.09	0.088 Score on a scale Interval -0.207 to 0.383

PRIMARY outcome

Timeframe: End of intervention, an average of 4 weeks

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Neurostimulation User Experience Attractiveness	3 Score on a scale Standard Deviation 0	2.5 Score on a scale Standard Deviation 0
Neurostimulation User Experience Perspicuity	1.5 Score on a scale Standard Deviation 0.707	1.917 Score on a scale Standard Deviation 0.382
Neurostimulation User Experience Efficiency	2.583 Score on a scale Standard Deviation 0.382	2 Score on a scale Standard Deviation 0.354
Neurostimulation User Experience Dependability	2.083 Score on a scale Standard Deviation 0.520	1.75 Score on a scale Standard Deviation 0.354
Neurostimulation User Experience Stimulation	2.917 Score on a scale Standard Deviation 0.144	2 Score on a scale Standard Deviation 0.354
Neurostimulation User Experience Novelty	2.583 Score on a scale Standard Deviation 0.382	1.75 Score on a scale Standard Deviation 1.414

PRIMARY outcome

Timeframe: Baseline, 4 Weeks, 8 Weeks, and 20 Weeks

Population: No Transcutaneous Epidural Stimulation arm participants were ambulatory.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=1 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Overground Ambulation [as Appropriate to the Subject] Pre-intervention to post-intervention	9.2 meters	—
Overground Ambulation [as Appropriate to the Subject] Pre-intervention to 8 weeks post intervention	16.5 meters	—
Overground Ambulation [as Appropriate to the Subject] Pre-intervention to 20 weeks post intervention	16.5 meters	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Trunk Stability Stimulation assisted reach	34.933333 centimeters Standard Deviation 14.115319	21.5 centimeters Standard Deviation 11
Trunk Stability Non-stimulation assisted reach	14.933333 centimeters Standard Deviation 9.3972809	3 centimeters Standard Deviation 3

PRIMARY outcome

Timeframe: Pre-intervention and 4 weeks post-intervention

Population: Analysis applies only to percutaneous group participants.

Evaluation of current array location via CT.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Neurostimulator Lead Location and Migration [Epidural Group Only]	-5.35862 millimeters Interval -8.48728 to -2.48357	—

PRIMARY outcome

Timeframe: Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.

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.

Outcome measures

Measure	Percutaneous Epidural Stimulation n=3 Participants 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=2 Participants 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Bladder Function Testing Pre-intervention	21 cm H2O Standard Deviation 15.769168	10.5 cm H2O Standard Deviation 5.5
Bladder Function Testing Post-intervention	54.666667 cm H2O Standard Deviation 32.148959	15 cm H2O Standard Deviation 15

Adverse Events

Percutaneous Epidural Stimulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Transcutaneous Epidural Stimulation

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Percutaneous Epidural Stimulation n=3 participants at risk 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=3 participants at risk 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.

Other adverse events

Measure	Percutaneous Epidural Stimulation n=3 participants at risk 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. Percutaneous epidural electrical spinal stimulation: Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System	Transcutaneous Epidural Stimulation n=3 participants at risk 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. Transcutaneous electrical spinal stimulation: Digitimer DS8R Bipolar Constant Current Stimulator
Skin and subcutaneous tissue disorders Petechiae	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.
Renal and urinary disorders Urinary incontinence	33.3% 1/3 • Number of events 2 • Adverse events were assessed over the course of approximately 20 weeks.	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.
Skin and subcutaneous tissue disorders Serosanguinous drainage	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.
Renal and urinary disorders Urinary tract infection	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.	66.7% 2/3 • Number of events 3 • Adverse events were assessed over the course of approximately 20 weeks.
Renal and urinary disorders Urethral irritation post urodynamics study	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.
Nervous system disorders Headache	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.
Vascular disorders Orthostatic hypotension	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	66.7% 2/3 • Number of events 2 • Adverse events were assessed over the course of approximately 20 weeks.
Musculoskeletal and connective tissue disorders Low back pain	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.
Nervous system disorders Presyncope	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.
Respiratory, thoracic and mediastinal disorders COVID-19 infection	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.
Gastrointestinal disorders Bowel incontinence	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	66.7% 2/3 • Number of events 2 • Adverse events were assessed over the course of approximately 20 weeks.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.
Nervous system disorders Autonomic dysreflexia	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 3 • Adverse events were assessed over the course of approximately 20 weeks.
Vascular disorders Hemorrhoids	0.00% 0/3 • Adverse events were assessed over the course of approximately 20 weeks.	33.3% 1/3 • Number of events 1 • Adverse events were assessed over the course of approximately 20 weeks.

Additional Information

Tyson Scrabeck

Mayo Clinic

Phone: 507-538-1016

Email: scrabeck.tyson@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place