CompletedNot Applicable

Stimulation to Enhance Walking Post-SCI

United States8 participantsStarted 2019-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in 10-Meter Walk Test (Interventional)

Timeframe: Baseline; Week 4

Change in Plantar Flexor Muscle Electromyogram Activation During Walking (Immediate Effects)

Timeframe: Baseline; 1 hour

Trial details

NCT IDNCT03702842

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-02

Results submitted2022-10-10

View on ClinicalTrials.gov More SCI - Spinal Cord Injury trials