Brain-Controlled Spinal Stimulation for Incomplete Spinal Cord Injury
This study is testing a new therapy called BCI-TSCS (Brain-Computer Interface-Transcutaneous Spinal Cord Stimulation) to see if it can help people with an incomplete spinal cord injury (SCI) improve their walking. You might be able to join if you are between 18 and 70 years old and have an incomplete spinal cord injury that happened more than 6 months ago. The researchers will be looking to see if the therapy causes any new neurological problems or side effects, and how many people complete the study. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 12 participants.
- What's involved
- Participants will receive BCI-TSCS therapy 3-4 times per week, which includes activity-based training.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months to measure neurological changes, side effects, and study completion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Matija Milosevic, PhD · PRINCIPAL_INVESTIGATOR · University of Miami - MSOM
Who to contact
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What this trial measures
- Number of related neurological deterioration (LEMS)up to 12 months
Lower Extremity Motor Score (LEMS) to assess lower limb muscle function following the American Spinal Injury Association Impairment Scale (ASIA) guidelines. The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function).
- Number of treatment related incidence of adverse events (AEs)up to 12 months
Safety will be reported as the incidence of treatment related AEs as assessed by the study doctor
- Number of subjects that complete the studyup to 12 months
Safety will be determined by number of subjects that complete the study, as designed.
- Walking function using 10 meter walk test (10MWT)up to 12 months
This is a test of short-distance walking function. The subject will be asked to walk at a comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway. Time is measured in meters per seconds.
- Walking function using 6 minute walk test (6MWT)up to 12 months
The object of the test is to walk as far as possible for 6 minutes. The subject will walk at a normal pace around a marked course for 6 minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a subject walks, the better their cardiovascular condition. Units are measured in meters.