BCI Technology for Stroke Rehabilitation

Overseen By Suzanne Hanson, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Other neurological, psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using brain signals to guide muscle stimulation can help stroke patients regain better arm use. Researchers aim to determine if this approach can improve movement and alter brain function. Participants will be divided into two groups: one using brain-guided muscle stimulation with Brain-Computer Interface (BCI) technology and the other using a standard approach. Ideal candidates for the trial experienced an ischemic stroke within the last year, are right-hand dominant, and have arm weakness from the stroke. As an unphased trial, this study offers the opportunity to contribute to groundbreaking research that could enhance stroke recovery methods.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this BCI technology is safe for stroke rehabilitation?

A previous study showed that functional electrical stimulation (FES) yielded promising results for stroke recovery. Patients using FES experienced better arm movement and improved quality of life. A review of 25 studies confirmed these positive outcomes.

Research has shown that brain-computer interface (BCI) technology is safe and can enhance arm movement in stroke patients. BCI training allows for repeated and safe rehabilitation, encouraging patient participation.

Overall, both FES and BCI treatments appear well-tolerated and beneficial for stroke recovery. Various studies have tested these treatments, demonstrating positive results for safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional stroke rehabilitation methods that often rely on physical and occupational therapy, the new approach using Brain-Computer Interface (BCI) technology is a game-changer. Researchers are excited because this method employs EEG-guided muscle stimulation, allowing for more precise and targeted therapy. This innovative technique could potentially enhance neural recovery by directly engaging the brain's signals to stimulate muscle movement, offering a more personalized and effective rehabilitation process. The use of functional electric stimulation (FES) tailored by EEG feedback is what sets this apart from conventional passive stimulation techniques, providing hope for faster and more significant recovery outcomes.

What evidence suggests that this BCI technology is effective for stroke rehabilitation?

Research has shown that Brain-Computer Interface (BCI) technology holds promise for stroke recovery. Studies have found that BCI-based therapy can enhance arm and hand movement in stroke patients. In this trial, participants will be randomized into different treatment arms. One arm will involve Active Functional Electric Stimulation (FES), which includes EEG-guided muscle stimulation. Another arm will involve Passive FES, which is non-EEG guided.

Functional Electric Stimulation (FES) also aids in stroke recovery. A review of several studies found that FES can improve movement control when used within two months after a stroke. This suggests that FES may be particularly helpful for recovering movement in the arms and hands. ^{1 5 6 7 8}

Who Is on the Research Team?

Vivek Prabhakaran, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for stroke patients with mild to severe weakness in one arm, who can consent for themselves, and were right-handed before the stroke. They should have had their first stroke within the last year and not be receiving other arm therapies or have pre-existing conditions affecting their arms.

Inclusion Criteria

My right hand is my dominant hand and it is affected.

I have arm weakness or difficulty moving my arm on one side.

Must be able to provide informed consent on their own behalf

Exclusion Criteria

I am receiving therapy for my arm or have a neurological or psychiatric condition.

I am able to understand and follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either active or passive FES intervention, including EEG guided muscle stimulation, behavioral assessments, fMRI, and FES treatment

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Electric Stimulation (FES)
• Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

Trial Overview The study tests if using brain signals (EEG) to control muscle stimulation helps improve arm function after a stroke. It involves behavioral assessments, brain scans (fMRI), and functional electric stimulation over about 4 months.

How Is the Trial Designed?

Group I: Active FES Experimental Treatment 4 Interventions

Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.

Group II: Passive FES Active Control 3 Interventions

Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739305/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1052305725000588

Effect of electrical stimulation in the treatment on patients ... The ES improved the lower limb motor function of patients in the recovery phases better than those in the acute phases, and the efficacy was not significant in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04876703

Effectiveness of Multichannel Functional Electrical ... Complete recovery of UE function is only reported in 11.6% of stroke survivors 6 months following ischemic middle cerebral artery stroke (Kwakkel, 2003). Neuro ...

4. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-017-0435-5

Effectiveness of upper limb functional electrical stimulation ... This review found a statistically significant benefit from FES applied within 2 months of stroke on the primary outcome of ADL.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40535619/

Functional electrical stimulation enhances motor control in ... Results: The study found that integrating electrical stimulation with early rehabilitation markedly enhanced stroke patients' recovery.

6. obrienphysicaltherapy.net obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectiveness

Post-Stroke Rehabilitation Outcomes: Statistics on Physical ... Patients receiving higher doses of rehabilitation—ranging from 20 to 300 hours—experience significant improvements in motor impairment and ...

7. karger.com karger.com/ced/article/53/6/743/893260/Meta-Analysis-of-Functional-Electrical-Stimulation

Meta-Analysis of Functional Electrical Stimulation ... In patients with stroke, both FES combined with OT and tDCS combined with OT exhibit substantial enhancements in limb function and quality of life compared to ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1877065718314088

Adding electrical stimulation during standard rehabilitation ... Electrical sensory input can contribute to routine rehabilitation to improve early post-stroke lower-extremity impairment and late motor function.