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Device

Epidural Stimulation + Resistance Training for Spinal Cord Injury (REST-SCI Trial)

Phase 2 & 3
Recruiting
Led By Ashraf S Gorgey, PhD
Research Sponsored by United States Department of Defense
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants will be between 18-60 years old, male or female, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam.
All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 6 months for 12 months
Awards & highlights
No Placebo-Only Group

REST-SCI Trial Summary

This trial is investigating whether adding 6 months of resistance training to epidural stimulation and assisted walking can help people with spinal cord injuries to recover motor control, improve cardiovascular health, and regain bladder control.

Who is the study for?
This trial is for adults aged 18-60 with traumatic motor complete spinal cord injury (SCI) at T10 level or above. They must have intact neural circuitry below the SCI as confirmed by tests, and fit specific criteria like having certain muscle responses. People with severe bone density loss, unhealed fractures, major cardiovascular issues, untreated severe spasticity or pressure sores, among other exclusions, cannot participate.Check my eligibility
What is being tested?
The study is testing whether using an 'ES Robot Suit' combined with resistance training can improve movement control in people who are paralyzed due to SCI. It compares those who use the suit with epidural stimulation alone to those who also do resistance training for better muscle quality and overall health.See study design
What are the potential side effects?
Potential side effects may include discomfort from the device or stimulation, skin irritation where electrodes are placed, increased spasticity or muscle spasms during use of the equipment. There's also a risk of falls when using walking devices.

REST-SCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18-60 years old with a spinal cord injury above T10, confirmed by tests.
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I have a spinal injury classified as AIS A or B, showing motor deficit below the injury level.
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I am 18-60 years old with a spinal cord injury above T10, confirmed by tests.
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I have a spinal injury classified as AIS A or B, meaning I have motor deficits below the injury level.
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I am between 18 and 60 years old.
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My leg muscles respond to electrical stimulation after my spinal cord injury.
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I have a spinal injury classified as AIS A or B with motor issues below the injury.
Select...
My spinal cord injury is severe, above T10, and confirmed by tests.

REST-SCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every 6 months for 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 6 months for 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 10-meter over ground walking-speed
Change in EMG Pattern
Secondary outcome measures
Change in Oxygen uptake
Changes in Systolic and Diastolic Blood Pressure
Changes in regional fat mass
Other outcome measures
Changes in Bladder Filling and Emptying using Fluoroscopy and EMG

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

REST-SCI Trial Design

2Treatment groups
Experimental Treatment
Group I: EAW+ES+RTExperimental Treatment3 Interventions
The exoskeletal assisted walking with epidural simulation and resistance training (EAW+ES+RT) group will undergo 6 months of supervised EAW +ES (3X per week) followed by additional 6 months of EAW+ES (3X per week) and progressive RT twice weekly (2X per week). In the EAW+ES+RT group, RT will be administered for 12 weeks using an open kinematic chain approach of applying surface NMES and ankle weights followed by 12 weeks twice weekly of gradually using the implanted ES to perform sit-to-stand approach (i.e. using their body weights to load the exercising muscles in a closed kinematic fashion).
Group II: EAW+ delayed-ES +no-RTExperimental Treatment3 Interventions
The control exoskeletal assisted walking with delayed epidural simulation and without resistance training (EAW+ delayed-ES +no-RT) group will enroll in 6 months of EAW without ES (3X per week) and then this will be followed by additional 6 months (3x per week) of EAW+ES (i.e., delayed entry approach) without conducting RT and will perform either passive movement of passive stretching (2X per week).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistance Training
2019
Completed Phase 2
~1190

Find a Location

Who is running the clinical trial?

United States Department of DefenseLead Sponsor
846 Previous Clinical Trials
224,471 Total Patients Enrolled
Central Virginia VA Health Care SystemUNKNOWN
Ashraf S Gorgey, PhDPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Epidural Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04782947 — Phase 2 & 3
Spinal Cord Injury Research Study Groups: EAW+ES+RT, EAW+ delayed-ES +no-RT
Spinal Cord Injury Clinical Trial 2023: Epidural Stimulation Highlights & Side Effects. Trial Name: NCT04782947 — Phase 2 & 3
Epidural Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782947 — Phase 2 & 3
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04782947 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If I meet the requirements, may I sign up for this research project?

"This study is willing to enroll 20 participants that have spinal cord injuries and are between 18-60 years old."

Answered by AI

Are elders welcome to participate in this clinical trial?

"This particular clinical trial is for patients aged 18-60, though there are 39 trials specifically for minors and 323 trials for senior citizens."

Answered by AI

Are there any empty slots in this clinical trial for patients who want to participate?

"Yes, that is correct. The clinical trial in question was posted on February 3rd 2021 and updated February 2nd of this year. They are looking for a total of 20 patients from a single location."

Answered by AI

How many total people can join this clinical trial?

"That is right, the details available on clinicaltrials.gov show that this trial is currently looking for volunteers. The listing was first put up on February 3rd, 2021 and was updated most recently on February 2nd, 2022. They need 20 individuals total from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Virginia
Pennsylvania
What site did they apply to?
Hunter Holmes McGuire VA Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I want to help others and recover.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

If I qualify, when is the earliest I can get a screening?
PatientReceived 1 prior treatment
~7 spots leftby Aug 2025