N/A
N=8
Stimulation to Enhance Walking Post-SCI
SCI - Spinal Cord Injury · Incomplete Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT03702842 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in 10-Meter Walk Test (Interventional) — 0.18; -0.05 meters/second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Soterix Medical tsDCS stimulator (Device); Locomotor training (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 10-Meter Walk Test (Interventional) |
0.18; -0.05 | — |
| PRIMARY Change in Plantar Flexor Muscle Electromyogram Activation During Walking (Immediate Effects) |
0.0102; -0.0023 | — |
| SECONDARY Change in 6-Minute Walk Test (Interventional) |
36.4; 4.9 | — |
Summary
This pilot study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury. Following rehabilitation, individuals with ISCI often demonstrate improved walking function, but continue to have serious impairments that limit mobility, community participation and quality of life. Adjuvants to rehabilitation that increase spinal excitation during training may enhance its effectiveness. tsDCS is a non-invasive neuromodulation approach that uses a mild electrical current, applied over the skin of the low back, to alter the membrane potential of spinal neurons. tsDCS will be applied during locomotor training, a well-established rehabilitation strategy that promotes walking recovery. Locomotor training emphasizes repetitive and task-specific practice of coordinated walking, often with therapist assistance or cueing to promote high quality movement patterns. The study team will explore if tsDCS combined with locomotor training increases spinal excitation and thereby improves the effectiveness of walking rehabilitation.
Eligibility Criteria
Inclusion Criteria
- Single spinal cord injury (duration >1 year) classified as neurologic level T12 or above based on the International Standards for the Neurologic Classification of Spinal Cord Injury, and classified on the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) as 'C' or 'D' motor incomplete
- Capable of ambulating 10 feet with or without the use of gait devices, braces, or the assistance of one person
- Medically stable with no acute illness or infection
- Able to provide informed consent
Exclusion Criteria
- Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
- Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction (<1 year), pulmonary infection or illness, renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification
- Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent
- Lower extremity joint contractures limiting the ability to stand upright and practice walking
- Skin lesions or wounds affecting participation in walking rehabilitation
- Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitation
- Severe spasticity or uncontrolled movements limiting participation in walking rehabilitation
- Body weight or height that is incompatible with safe use of a support harness and body weight support system
- Pain that limits walking or participation in walking rehabilitation
- Current participation in rehabilitation to address walking function
- Botox injections in lower extremity muscles affecting walking function within 4 months of study enrollment
- Legal blindness or severe visual impairment
- Known pregnancy
- Implanted metal hardware below the level of the 8th thoracic vertebrae
Data sourced from ClinicalTrials.gov (NCT03702842). 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.