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Recruiting NCT05700942

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

Conditions: Spinal Cord Injuries

Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 18
Sponsor: University of Florida

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Adults 18 to 65 years of ageSingle 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 screeningMedical stability with clearance from physicianAbility to walk 3 meters with or without devices, braces, or assistance of one personAbility to provide informed consent.Exclusion Criteria:Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injuryPresence 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 ossificationCognitive or communication impairments limiting communication with study staff or ability to provide informed consentLower extremity joint contractures limiting the ability to stand upright and practice walkingSkin lesions or wounds affecting participation in walking rehabilitationAcute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitationSevere spasticity or uncontrolled movements limiting participation in walking rehabilitationBody weight or height that is incompatible with safe use of a support harness and body weight support systemPain that limits walking or participation in walking rehabilitationCurrent participation in rehabilitation to address walking functionBotox injections in lower extremity muscles affecting walking function within 4 months of study enrollmentLegal blindness or severe visual impairmentKnown pregnancyImplanted metal hardware of the spine below the 8th thoracic vertebrae or in region of electrode placementImplanted cardiac pacemaker or baclofen pump

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Source: ClinicalTrials.gov (NCT05700942). StuddyBuddy aggregates publicly available trial information.