Phase 2
N=4
Neuromodulation Techniques After SCI
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT04241250 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: 10-meter Walking Speed (m/Sec) — 0.165; 0.215; 0.13; 0.13 speed (m/sec)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EAW+SCES (exoskelton and spinal cord epidural stimulation) (Device); EAW+TS (exoskelton and transspinal stimulation) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 10-meter Walking Speed (m/Sec) |
0.165; 0.215; 0.13; 0.13 | — |
| PRIMARY Muscles Electromyography (EMG) Activity (Micro-volts) |
0.000045; 0.0129; 0.00011085; 0.013915; 0.016705 | — |
| SECONDARY Percentage Fat Mass |
25.6; 30.1; 23.9; 20.0; 22.3 | — |
| SECONDARY Oxygen Uptake (L/Min) |
1.08; 0.7; 0.84 | — |
| SECONDARY Fasting Lipid Profile (mg/dl) |
158; 142; 137; 112; 74; 75 | — |
| SECONDARY Fat-Free Mass |
52.6; 46.5; 52.6; 55.0; 55.0 | — |
Summary
Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent standing and stepping. These current methods require 3-4 highly skilled therapists and may not be feasible in all rehabilitation settings, especially when considering the growing number of SCI patients each year. Therefore, the use of robotic exoskeleton suits combined with direct stimulation of the spinal cord (requiring 1-2 therapists) may offer an alternative rehabilitation approach to overcome their limited abilities to stand and walk. Such improvements may also help to reverse or eliminate other health-related consequences associated with SCI. The pilot work will provide the preliminary evidence required to design future clinical trials for Veterans and civilians with SCI to restore overground mobility.
Eligibility Criteria
Inclusion Criteria
- All participants will be between 18-70 years old, male, 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
Exclusion Criteria
Participants with any of the following pre-existing medical conditions will be excluded from the current trial:
- 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
- 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 recommendations
- 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
Data sourced from ClinicalTrials.gov (NCT04241250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.