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RECRUITING

NCT05700942

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

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

Official title: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After Spinal Cord Injury

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-03-10

Completion Date

2026-06

Last Updated

2025-11-25

Healthy Volunteers

Conditions

Spinal Cord Injuries

Interventions

DEVICE

High Dose Intervention-tsDCS

Subjects will receive a high dose tsDCS (2.5mA, 30 mins) LT (4x/week, 5 weeks)

DEVICE

Low Dose Intervention-tsDCS

Subjects will receive a low dose tsDCS (2.5mA, 30 mins) LT (4xweek/ 5 weeks)

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

Locations (1)

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States