BCI-FES Therapy for Stroke Rehabilitation
Trial Summary
What is the purpose of this trial?
There are over 7 million stroke survivors in the US alone, with approximately 795,000 new cases annually. Despite the best available physiotherapy, 30-60% of stroke survivors remain affected by difficulty walking, with foot weakness often being the main cause. Given that post-stroke gait impairments remain poorly addressed, new methods that can provide lasting improvements are necessary. Brain-computer interface (BCI) technology may be one such novel approach. BCI technology enables "direct brain control" of external devices such as assistive devices and prostheses by translating brain waves into control signals. When BCI systems are integrated with functional electrical stimulation (FES) systems, they can be used to deliver a novel physical therapy to improve movement after stroke. BCI-FES systems are hypothesized to stimulate recovery after stroke beyond that of conventional physical therapy.
Eligibility Criteria
This trial is for stroke survivors aged 18-80, at least 26 weeks post-stroke, with walking difficulties due to foot weakness. They must be able to walk over 10 meters and tolerate FES therapy. Excluded are those with recent Botox in legs, severe depression, other major medical issues affecting gait, concurrent physical therapy or investigational studies, implanted electronic devices or metal in the skull.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo BCI-FES therapy or dose-matched conventional physical therapy for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BCI-FES dorsiflexion therapy
- Physiotherapy one hour
- Physiotherapy two hours
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor