Incomplete Spinal Cord Injury Clinical Trial
Official title:
Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotion After Spinal Cord Injury
Verified date | November 2021 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury. Following rehabilitation, individuals with ISCI often demonstrate improved walking function, but continue to have serious impairments that limit mobility, community participation and quality of life. Adjuvants to rehabilitation that increase spinal excitation during training may enhance its effectiveness. tsDCS is a non-invasive neuromodulation approach that uses a mild electrical current, applied over the skin of the low back, to alter the membrane potential of spinal neurons. tsDCS will be applied during locomotor training, a well-established rehabilitation strategy that promotes walking recovery. Locomotor training emphasizes repetitive and task-specific practice of coordinated walking, often with therapist assistance or cueing to promote high quality movement patterns. The study team will explore if tsDCS combined with locomotor training increases spinal excitation and thereby improves the effectiveness of walking rehabilitation.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | September 5, 2022 |
Est. primary completion date | September 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Single spinal cord injury (duration >1 year) classified as neurologic level T12 or above based on the International Standards for the Neurologic Classification of Spinal Cord Injury, and classified on the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) as 'C' or 'D' motor incomplete - Capable of ambulating 10 feet with or without the use of gait devices, braces, or the assistance of one person - Medically stable with no acute illness or infection - Able 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), 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 below the level of the 8th thoracic vertebrae |
Country | Name | City | State |
---|---|---|---|
United States | Brooks Rehabilitation Hospital | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Brooks Rehabilitation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 10-Meter Walk Test (Interventional) | 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 4 | |
Primary | Change in Electromyogram (EMG; Immediate) | EMG will be used to assess the neuromuscular activation of the lower extremity muscles. A wireless, 16-channel EMG system will be applied at various key muscle groups on both lower extremities. Greater amplitude or changes in activation timing in the EMG signal will reflect improvement in muscle activation. | Baseline; 1 hour | |
Secondary | Change in 6-Minute Walk Test (Interventional) | The 6-Minute Walk Test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance. | Baseline; Week 4 |
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