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

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

A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

Study Overview

• Status: Completed
• Conditions: Paralysis; Tetraplegia; Paraplegia; Quadraplegia
• Intervention / Treatment: Device: Percutaneous epidural electrical spinal stimulation; Device: Transcutaneous electrical spinal stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Percutaneous epidural electrical spinal stimulation; Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System
Experimental: 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.	Device: Transcutaneous electrical spinal stimulation; Digitimer DS8R Bipolar Constant Current Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion; an average of 5 months.
Foot Pressure	Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.	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.	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.	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).	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.	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.

Collaborators and Investigators

• Sponsor: Kristin Zhao, PhD
• Investigators: Principal Investigator: Kristin D Zhao, Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Quadriplegia; Paraplegia
• Other Study ID Numbers: 21-006340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes