AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT05700942
- Lead Sponsor
- University of Florida
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria:<br><br> - Adults 18 to 65 years of age<br><br> - Single chronic SCI for = 1 year classified as neurologic level T12 or above based on<br> the International Standards for the Neurological Classification of SCI67 and<br> classified according to the American Spinal Injury Association Impairment Scale<br> (AIS) as motor incomplete (AIS C or D) at initial screening<br><br> - Medical stability with clearance from physician<br><br> - Ability to walk 3 meters with or without devices, braces, or assistance of one<br> person<br><br> - Ability to provide informed consent.<br><br>Exclusion Criteria:<br><br> - Current diagnosis of an additional neurologic condition such as multiple sclerosis,<br> Parkinson's disease, stroke, or brain injury<br><br> - Presence of unstable or uncontrolled medical conditions such as cardiovascular<br> disease, myocardial infarction (<1 year prior), pulmonary infection or illness,<br> renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification<br><br> - Cognitive or communication impairments limiting communication with study staff or<br> ability to provide informed consent<br><br> - Lower extremity joint contractures limiting the ability to stand upright and<br> practice walking<br><br> - Skin lesions or wounds affecting participation in walking rehabilitation<br><br> - Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments<br> affecting safe participation in walking rehabilitation<br><br> - Severe spasticity or uncontrolled movements limiting participation in walking<br> rehabilitation<br><br> - Body weight or height that is incompatible with safe use of a support harness and<br> body weight support system<br><br> - Pain that limits walking or participation in walking rehabilitation<br><br> - Current participation in rehabilitation to address walking function<br><br> - Botox injections in lower extremity muscles affecting walking function within 4<br> months of study enrollment<br><br> - Legal blindness or severe visual impairment<br><br> - Known pregnancy<br><br> - Implanted metal hardware of the spine below the 8th thoracic vertebrae or in region<br> of electrode placement<br><br> - Implanted cardiac pacemaker or baclofen pump
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in 10-Meter Walk Test (10MWT);Change in 6-Minute Walk Test (6MWT);Change in H-Reflex Post Activation Depression;Change in H-Reflex Gait Phase Modulation
- Secondary Outcome Measures
Name Time Method