Epidural Stimulation and Resistance Training After SCI
REST-SCI
1 other identifier
interventional
20
1 country
1
Brief Summary
Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable "robot suits" that can be used with ES, which would make it easier to use. Our research team has already used this "ES Robot Suit" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2021
CompletedFirst Submitted
Initial submission to the registry
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
January 2, 2026
December 1, 2025
5.3 years
February 26, 2021
December 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in 10-meter over ground walking-speed
The investigators will measure the speed of walking and the time elapsed during 10 meter distance.
Baseline to 12 months
Change in EMG Pattern
The investigators will record muscle activity from the major lower extremity muscle groups.
Baseline to 12 months
Secondary Outcomes (3)
Changes in Systolic and Diastolic Blood Pressure
Baseline to 12 months
Changes in regional fat mass
Baseline to 12 months
Change in Oxygen uptake
baseline and every 6 months for 12 months
Other Outcomes (1)
Changes in Bladder Filling and Emptying using Fluoroscopy and EMG
Baseline to 12 months
Study Arms (2)
EAW+ES+RT
EXPERIMENTALThe 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).
EAW+ delayed-ES +no-RT
EXPERIMENTALThe 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).
Interventions
Exoskeletal assisted walking includes the use of robotic suit to train participant to walk with different level of assistance.
lumbo-sacral epidural simulation at the beginning of the study.
Using two forms of resistance training to increase muscle size. The first form includes seated leg extension exercise for 12 weeks followed by a second form that includes sit-to-stand exercise using participant's body weight.
lumbo-sacral epidural simulation starting 6 months after the beginning of the study.
The participants will perform 24 weeks of passive movement or passive stretching from seated position.
Eligibility Criteria
You may qualify if:
- 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 (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI.
- 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.
You may not qualify if:
- Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia;
- Unhealed fracture in either lower or upper extremities;
- Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees.
- Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture;
- Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection;
- Unable to fit in the device for any reason;
- Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons;
- Implanted pacemakers and/or implanted defibrillator devices;
- DXA T-Score less than -2.5. Scans done will include total body, dual hips and knees. Total hip BMD T-scores \< -3.5 and knee BMD scores of less than 0.6 g/cm2 68-71;
- Functional upper and lower extremity ROM, strength, spasticity and skin integrity will also have assessed prior to enrollment in the program. The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program. Participants with severe spasticity or limited ROM will be excluded from the trial. This is based on the Ekso® manufacturer's recommendations72;
- Untreatable severe spasticity judged to be contraindicated by the site Physician;
- Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more;
- Psychopathology documentation in the medical record or history that may conflict with study objectives;
- Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and/or increases the risk of infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Related Publications (1)
Gorgey AS, Goldsmith J, Alazzam A, Trainer R. Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. Front Neurosci. 2023 Feb 16;17:1112853. doi: 10.3389/fnins.2023.1112853. eCollection 2023.
PMID: 36875669DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashraf S Gorgey, PhD
Virginia Commonwealth University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of SCI Research
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 4, 2021
Study Start
February 3, 2021
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share