Epidural stimulation and resistance training for spinal cord injury recovery

Epidural Stimulation and Resistance Training for Overground Locomotion After Spinal Cord Injury

This study is testing whether combining epidural stimulation with assisted walking and strength training can help people with spinal cord injuries improve their movement and muscle strength.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: United States Department of Defense (Federal)
• Locations: 1 site (Richmond, Virginia)
• Trial ID: NCT04782947 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combining epidural stimulation (ES) with exoskeletal assisted walking (EAW) and resistance training (RT) to improve motor recovery in individuals with spinal cord injuries (SCI). Participants will engage in a structured program that includes EAW and ES to facilitate standing and walking, along with RT to enhance muscle strength and quality. The goal is to address the limitations of current rehabilitation methods by making the process more accessible and effective for patients. The study aims to evaluate the combined impact of these interventions on motor control and muscle hypertrophy over a six-month period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with traumatic motor complete spinal cord injuries at the T10 level or above.

Not a fit: Patients with neurological injuries other than SCI or those with unhealed fractures or severe musculoskeletal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve mobility and quality of life for individuals with spinal cord injuries.

How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly in the use of epidural stimulation and exoskeletal devices for rehabilitation.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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.
3. 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.

Exclusion Criteria:

1. Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia;
2. Unhealed fracture in either lower or upper extremities;
3. Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees.
4. 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;
5. 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;
6. Unable to fit in the device for any reason;
7. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons;
8. Implanted pacemakers and/or implanted defibrillator devices;
9. 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;
10. 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;
11. Untreatable severe spasticity judged to be contraindicated by the site Physician;
12. Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more;
13. Psychopathology documentation in the medical record or history that may conflict with study objectives;
14. 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.

Where this trial is running

Richmond, Virginia

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Ashraf S Gorgey, PhD — Virginia Commonwealth University
• Study coordinator: Ashraf S Gorgey, PhD

Conditions Spinal Cord Injuries; neuromodulation; epidural simulation; exoskeletal assisted walking; resistance training; rehabilitation