Status:
RECRUITING
Epidural Stimulation and Resistance Training After SCI
Lead Sponsor:
United States Department of Defense
Collaborating Sponsors:
Central Virginia VA Health Care System
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
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...
Detailed Description
Spinal cord epidural stimulation (ES) is a neuromodulation modality that can facilitate standing, stepping and walking with and without assistive devices in individuals with SCI, however; ES must be a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04782947
Start Date
February 3 2021
End Date
May 31 2026
Last Update
January 2 2026
Active Locations (1)
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1
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249