Active — Not RecruitingNot Applicable

AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI

United States18 participantsStarted 2023-03-10

Plain-language summary

Locomotor training (LT) facilitates recovery of spinal locomotor networks after incomplete spinal cord injury (ISCI), but walking impairments persist. A limitation of LT is insufficient excitation of spinal locomotor circuits to induce neuroplastic recovery. Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive approach to increase spinal excitation and modulate spinal reflexes. The study will examine if tsDCS combined with LT enhances locomotor rehabilitation after ISCI.

Who can participate

Age range18 Years – 65 Years

SexALL

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

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 sa…

What they're measuring

Change in 10-Meter Walk Test (10MWT)

Timeframe: Baseline, Week 6, Week 8

Change in 6-Minute Walk Test (6MWT)

Timeframe: Baseline, Week 6, Week 8

Change in H-Reflex Post Activation Depression

Timeframe: Baseline, Week 6

Change in H-Reflex Gait Phase Modulation

Timeframe: Baseline, Week 6

Trial details

NCT IDNCT05700942

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05