Transcutaneous spinal stimulation to improve walking after spinal cord injury
Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After Spinal Cord Injury
This study is testing if a new method using electrical stimulation on the spine, combined with walking training, can help people with partial spinal cord injuries walk better and improve their endurance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05700942 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous spinal direct current stimulation (tsDCS) combined with locomotor training (LT) on individuals with incomplete spinal cord injuries (ISCI). The approach aims to enhance spinal excitation and modulate reflexes to improve walking outcomes. Participants will undergo a double-blind, randomized parallel-group design, receiving either tsDCS with LT or a sham treatment with LT over 20 sessions. The primary outcomes will focus on changes in walking speed and endurance, as well as spinal motor excitability and reflex modulation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with chronic, motor incomplete spinal cord injuries classified as AIS C or D.
Not a fit: Patients with additional neurological conditions or unstable medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for patients with spinal cord injuries, improving their mobility and quality of life.
How similar studies have performed: Previous studies have shown promise for tsDCS in enhancing locomotor rehabilitation, but this specific combinatorial approach has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 to 65 years of age * Single chronic SCI for ≥ 1 year classified as neurologic level T12 or above based on the International Standards for the Neurological Classification of SCI67 and classified according to the American Spinal Injury Association Impairment Scale (AIS) as motor incomplete (AIS C or D) at initial screening * Medical stability with clearance from physician * Ability to walk 3 meters with or without devices, braces, or assistance of one person * Ability 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 prior), 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 of the spine below the 8th thoracic vertebrae or in region of electrode placement * Implanted cardiac pacemaker or baclofen pump
Where this trial is running
Jacksonville, Florida
- Brooks Rehabilitation Hospital — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Emily Fox, DPT, PhD — University of Florida
- Study coordinator: Hannah Snyder, MS
- Email: hannah.snyder@brooksrehab.org
- Phone: 904-345-6910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.