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

Phase 2 & 3
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.
Participants' knee extensors must respond to standard surface NMES procedures to ensure intact neural circuitry below the level of SCI
Must not have
Pressure ulcer of grade 3 or more
Untreated or uncontrolled hypertension and severe orthostatic hypotension
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 6 months for 12 months
Awards & highlights


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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I have a severe pressure ulcer.
I have high blood pressure that isn't managed or severe dizziness when standing up.
I do not have severe scoliosis or joint issues that prevent me from using an exoskeleton.
I have a fracture in my arm or leg that hasn't healed.
I do not have severe heart disease, unmanaged diabetes, high blood pressure, major skin sores, or a serious urinary infection.
I have a neurological injury that affects my limbs or lower back, not caused by spinal cord injury.


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

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).
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistance Training
Completed Phase 2

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lumbosacral epidural stimulation (ES) combined with a wearable robot suit (EAW) is a promising treatment for spinal cord injury (SCI) that works by delivering electrical currents to the spinal cord to enhance motor control and facilitate movement. This stimulation helps to activate neural circuits below the site of injury, promoting muscle contractions and improving motor function. The wearable robot suit assists in movement, providing support and enabling repetitive training, which is crucial for neuroplasticity and motor recovery. These mechanisms are vital for SCI patients as they can lead to significant improvements in mobility, independence, and overall quality of life.

Find a Location

Who is running the clinical trial?

United States Department of DefenseLead Sponsor
875 Previous Clinical Trials
329,966 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
~5 spots leftby Aug 2025