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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help stroke survivors improve their walking abilities. It tests a combination of brain-computer interface (BCI) technology and functional electrical stimulation (FES) to determine if it enhances recovery more effectively than regular physical therapy alone. The study compares BCI-FES dorsiflexion therapy with two types of physiotherapy sessions, one lasting one hour and the other two hours. Individuals who have experienced a stroke, have difficulty lifting their foot when walking (foot-drop), and can walk at least 10 meters may be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance stroke recovery therapies.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medications that affect seizure threshold, like tricyclic antidepressants or neuroleptics, you may not be eligible for certain procedures in the study.

What prior data suggests that this BCI-FES therapy is safe for stroke rehabilitation?

Research has shown that BCI-FES therapy, which combines brain-computer interface technology with electrical stimulation, is safe for stroke recovery. Studies suggest this treatment can improve walking and is well-tolerated by patients. These studies have reported no major safety issues.

For physiotherapy, research consistently finds that increased physical therapy, such as two-hour sessions, leads to better recovery for stroke patients. This therapy is very safe and is a standard part of stroke recovery.

Overall, both BCI-FES therapy and two-hour physiotherapy sessions have strong safety records, making them promising options for improving mobility after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BCI-FES dorsiflexion therapy for stroke rehabilitation because it combines brain-computer interface (BCI) technology with functional electrical stimulation (FES), which is not part of the standard physiotherapy regimen. Unlike typical post-stroke therapies that focus solely on muscle exercises, this approach uses an EEG cap to translate brain signals into movements, potentially enhancing neuroplasticity and improving motor recovery more effectively. Meanwhile, the dose-and intensity-matched physiotherapy arm explores the impact of simply increasing physiotherapy duration to two hours, aiming to determine if more extended conventional therapy alone can yield similar benefits. This trial explores whether integrating advanced tech like BCI-FES or simply increasing therapy duration can significantly boost recovery after a stroke.

What evidence suggests that BCI-FES dorsiflexion therapy could be effective for stroke rehabilitation?

Research shows that BCI-FES therapy, which uses brain signals and electrical stimulation to help muscles move, can be effective for stroke recovery. Studies have found that this method can improve walking speed and foot movement after a stroke, potentially helping survivors walk better by directly addressing foot weakness. Early evidence suggests this therapy is safe and could lead to lasting improvements in movement. Participants in this trial may receive BCI-FES dorsiflexion therapy combined with one hour of physiotherapy.

For those in the trial receiving the two-hour physiotherapy treatment, evidence indicates that customized rehabilitation programs can improve balance, walking, and muscle strength after a stroke. Regular, personalized sessions can boost recovery even when progress seems slow. However, results can vary, especially for those facing severe stroke-related challenges. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

bmcneurol.biomedcentral.com

bmcneurol.biomedcentral.com/articles/10.1186/s12883-024-03710-3

A single-center, assessor-blinded, randomized controlled ...

This article outlines the design of a Phase II clinical trial that investigates the safety and potential efficacy of BCI-FES in rehabilitating ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4498504/

Brain-controlled functional electrical stimulation therapy for ...

Since this BCI-FES therapy appears to be safe and a large proportion of subjects experienced improvements in gait speed and dorsiflexion AROM, ...

3.

trialx.com

trialx.com/clinical-trials/listings/228727/bci-fes-therapy-for-stroke-rehabilitation/

BCI-FES Therapy for Stroke Rehabilitation

Preliminary research indicates that applying this technique to foot weakness after stroke is safe and may improve walking function. Hence, this warrants further ...

4.

frontiersin.org

frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1256077/full

Brain–computer interface treatment for gait rehabilitation in ...

The BCI treatment was effective in promoting long-lasting functional improvements in the gait speed of chronic stroke survivors.

5.

ahajournals.org

ahajournals.org/doi/10.1161/str.44.suppl_1.atp94

Abstract TP94: Brain-computer Interface Controlled ...

The results provide preliminary evidence that BCI-FES therapy is safe and may lead to neurological improvement. Therapy based on BCI has the potential to help a ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/str.44.suppl_1.ATP94?doi=10.1161/str.44.suppl_1.ATP94

Abstract TP94: Brain-computer Interface Controlled ...

The results provide preliminary evidence that BCI-FES therapy is safe and may lead to neurological improvement. Therapy based on BCI has the potential to ...

7.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1272992/full

A systematic review on functional electrical stimulation ...

The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb ...