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

Study Overview
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Brief Summary
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A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

Detailed Description
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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.

Official Title
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A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With Spinal Cord Injury

Conditions
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Paraplegia, Tetraplegia, Paralysis, Quadraplegia

Intervention / Treatment
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* Device: Percutaneous epidural electrical spinal stimulation
* Device: Transcutaneous electrical spinal stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10) American Spinal Injury Association grading scale of A-D (2 from each) below the level of SCI Intact spinal reflexes below the level of SCI At least 1-year post-SCI At least 22 years of age Willing to use medically acceptable methods of contraception, if female and of child-bearing potential Exclusion Criteria: Currently a prison inmate, or awaiting trial, related to criminal activity Pregnancy at the time of enrollment History of chronic and/or treatment resistant urinary tract infection Unhealed decubitus ulcer Unhealed skeletal fracture Untreated clinical diagnosis of depression Undergoing, or planning to undergo, diathermy treatment Active participation in another interventional clinical trial Presence of conditions or disorders which require MRI monitoring A history of coagulopathy or other significant cardiac or medical risk factors for surgery Current use of a ventilator Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping History of frequent hypotension characterized by light headedness, or loss of consciousness History of frequent hypertension characterized by headache, or bradycardia History of frequent, severe, autonomic dysreflexia Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Epidural Stimulation<br>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<br>* Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System<br>|
| Experimental: Transcutaneous Epidural Stimulation<br>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<br>* Digitimer DS8R Bipolar Constant Current Stimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematics | Change in measurements of joint angles, measured in degrees. | Through study completion; an average of 5 months. | 
| Electromyography | Change in voltage measurements in major muscle groups below the level of injury. | Through study completion; an average of 5 months. | 
| Foot pressure | Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors. | Through study completion; an average of 5 months. | 
| 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. | Through study completion; an average of 5 months. | 
| Transcranial magnetic stimulation motor evoked potentials | Measurement of change in voltage required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury. | Through study completion; an average of 5 months. | 
| Injury severity: International Standards for Neurological Classification of Spinal Cord Injury | Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale (AISA Scale). Individuals are classified from A (complete spinal cord injury) to E (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the 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 each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no. | Through study completion; an average of 5 months. | 
| 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. | Through study completion; an average of 5 months. | 
| 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. | Through study completion; an average of 5 months. | 
| 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. | Through study completion; an average of 5 months. | 
| 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. | Through study completion; an average of 5 months. | 
| 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. | Through study completion; an average of 5 months. | 
| 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. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. | Through study completion; an average of 5 months. | 
| 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. | End of intervention. | 
| 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. | Through intervention completion; an average of 4 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. | Through study completion; an average of 5 months. | 
| Neurostimulator lead location and migration [Epidural group only] | Evaluation of current array location via CT. | Beginning of study, prior to initiating intervention; End of 4 weeks of intervention. | 
| Bladder function testing | Change in measurements of bladder function utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography. | Beginning of study, prior to initiating intervention; End of 4 weeks of intervention. |