University of Washington
This trial is a double-blind, crossover, sham-controlled pilot study to evaluate the feasibility, safety, and preliminary efficacy of repeated transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal segments in adults with hereditary spastic paraplegias (HSPs) and other genetic causes of spasticity. The investigators will recruit four people with hereditary lower extremity spasticity who are able to ambulate with or without assistive devices to participate in the trial. The investigators will assess a range of outcome measures to evaluate tSCS in this patient population and to inform the design of a larger study.
Potential participants will be screened for study inclusion. Enrollees will undergo baseline testing, including clinical assessments, neurophysiological tests, and questionnaires. Participants will then undergo a four-week block of intensive locomotor training with a physical therapist with either active or sham spinal cord stimulation. During each block, participants will complete three sessions of training with active or sham stimulation per week for four weeks. The assessment battery will be completed at the beginning, midpoint, and end of the block. Participants will then undergo a 4-week…
Inclusion Criteria: 1. Participants cannot have severe lower extremity spasticity (Modified Ashworth Scale score of 4). 2. Participants must not have received botulinum toxin injections in the lower extremities within the previous four months. 3. Participants may not have joint contractures that limit passive range-of-motion by more than 15 degrees in the lower extremity joints. 4. Participants may not have an active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump. 5. Participants must not be actively taking dantrolene for spasticity. 6.…
Participants will undergo intensive locomotor training combined with transcutaneous spinal cord stimulation at T11-L1 level.
Participants will undergo intensive locomotor training combined with sham transcutaneous spinal cord stimulation at T11-L1 level.
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