Spinal Cord Injuries Clinical Trial
Official title:
Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After Spinal Cord Injury
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | September 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brooks Rehabilitation Hospital | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Brooks Rehabilitation, The Craig H. Neilsen Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 10-Meter Walk Test (10MWT) | Is a performance measure used to assess walking speed in meters per second over a short distance. Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function | Baseline, Week 6, Week 8 | |
Primary | Change in 6-Minute Walk Test (6MWT) | The distance that a patient should walk based on their height, weight, age, and gender. Performance assessment of walking endurance for 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance. | Baseline, Week 6, Week 8 | |
Primary | Change in H-Reflex Post Activation Depression | Assessment that quantifies the appropriate reduction in motor response to repeated sensory inputs. Increased post-activation depression (reduced motor response as measured with electromyography) reflects improved spinal modulation and may reflect normalization of an overactive stretch reflex. | Baseline, Week 6 | |
Primary | Change in H-Reflex Gait Phase Modulation | Assessment that quantifies the appropriate modulation of motor response to sensory input across the gait cycle. Improved modulation may reflect improved spinal rhythmic output to permit improved walking function. | Baseline, Week 6 |
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