BCI-FES Therapy for Stroke Rehabilitation

Overseen By An Do, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Tricyclic antidepressants, Neuroleptics

Disqualifiers: Alcoholism, Dementia, Orthopedic injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

66 Participants Needed

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

I can walk more than 10 meters, even if I need a cane, walker, or AFO.

I can move my ankle upwards to a flat position without help.

I can handle electrical stimulation with minimal pain and my foot lifts properly.

Exclusion Criteria

I have been diagnosed with severe depression.

I have had a stroke or brain tumor in the past.

I experience significant pain, chest pain, or shortness of breath when walking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo BCI-FES therapy or dose-matched conventional physical therapy for 4 weeks

4 weeks

12 sessions (in-person, 3x/week)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• BCI-FES dorsiflexion therapy
• Physiotherapy one hour
• Physiotherapy two hours

Trial Overview The study tests a new rehab method using brain-computer interface (BCI) combined with functional electrical stimulation (FES) against standard physiotherapy. It aims to see if this tech can better improve walking after a stroke by directly controlling assistive devices through brain waves.

Participant Groups

Group I: Dose-and intensity-matched physiotherapy Experimental Treatment 1 Intervention

Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week. In the dose-matched control group (Group 2), it will be 2 hours/session.

Group II: BCI-FES dorsiflexion therapy with physiotherapy Experimental Treatment 2 Interventions

Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform 20-25 BCI-FES runs. A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy. Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+