Brain Stimulation for Stroke Recovery

Overseen by Vivek Prabhakaran, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Infectious diseases, Oral lesions, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if stimulating arm muscles and sending gentle electrical signals through the tongue can help stroke patients recover better. It targets adults who have trouble moving their arms and hands after a stroke. The treatment uses a brain-computer system to help retrain the brain and muscles to work together.

Do I need to stop 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 data supports the effectiveness of the treatment BCI-FES for stroke recovery?

Research shows that BCI-FES, which combines brain-computer interface technology with electrical stimulation, can improve brain activation and motor function in stroke patients. Studies found that BCI-FES was more effective than electrical stimulation alone in enhancing brain activity and motor control. ^{1 2 3 4 5}

Is brain stimulation for stroke recovery safe for humans?

The studies on brain-computer interface-controlled functional electrical stimulation (BCI-FES) and the recoveriX system for stroke recovery do not report any safety concerns, suggesting that these treatments are generally safe for humans. ^{1 2 3 4 6}

How is the BCI-FES treatment for stroke recovery different from other treatments?

The BCI-FES treatment is unique because it combines brain-computer interface technology with functional electrical stimulation to enhance motor recovery after a stroke. This approach provides real-time feedback and stimulates brain activation more effectively than traditional electrical stimulation alone, potentially leading to better recovery outcomes. ^{1 2 3 4 7}

Research Team

Vivek Prabhakaran, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for stroke survivors with moderate arm impairment, who were independent before their stroke. It's not for those allergic to electrode gel or metals, pregnant women, people with MRI contraindications, infectious diseases, or oral lesions.

Inclusion Criteria

No known neurologic, psychiatric or developmental disability

I was independent in daily activities before my stroke.

You have factors that make you more likely to have a stroke.

Exclusion Criteria

You are allergic to the gel used for electrodes, surgical tape, or metals.

Women who are pregnant or may become pregnant during the course of the study will be excluded

I cannot have an MRI but can join other parts of the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo pre-intervention MRI and behavioral testing

1-2 weeks

1 visit (in-person)

Treatment

Participants receive EEG-BCI training with muscle and tongue stimulation

8-10 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for changes in EEG/fMRI and behavioral measures

4 months

2 visits (in-person)

Treatment Details

Interventions

• BCI-FES (Neurostimulation Device)
• RecoveriX (Neurostimulation Device)

Trial Overview The study tests if brain stimulation via the arm and tongue can help in stroke recovery. It involves behavioral assessments, electric muscle stimulation (FES), MRI scans, EEGs and a system called RecoveriX.

Participant Groups

Group I: Experimental Group - RecoveriX Experimental Treatment 1 Intervention

Recruited from participants who have completed the study intervention

Group II: Experimental Group - Immediate BCI Therapy Experimental Treatment 4 Interventions

EEG - BCI training (closed loop)

Group III: Experimental Group - Delayed BCI Therapy Experimental Treatment 5 Interventions

Scanned and tested 4 times over a 10-week period before EEG-BCI training

Group IV: Control Group 1 Active Control 4 Interventions

48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI

Group V: Control Group 2 Active Control 1 Intervention

24 Stroke Patients with UE impairment receiving standard FES only therapy

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Eduardo Sanchez

American Heart Association

Chief Medical Officer since 2013

MD from University of Texas Southwestern Medical School, MPH from UT Health Science Center at Houston, MS in Biomedical Engineering from Duke University

Katrina McGhee

American Heart Association

Chief Executive Officer since 2020

MBA from the University of Texas at Arlington

Findings from Research

In a study of 25 individuals with chronic hemiparetic stroke, those who received brain-computer interface-controlled functional electrical stimulation (BCI-FES) showed significant improvements in gait velocity and cadence compared to those who received standard functional electrical stimulation (FES).

BCI-FES also led to a greater increase in step length on the less-affected side, suggesting that this innovative approach may enhance walking abilities more effectively than traditional FES.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of brain-computer interface-controlled functional electrical stimulation training on balance and gait performance for stroke: A pilot randomized controlled trial. Chung, E., Lee, BH., Hwang, S.[2022]

The study demonstrated that combining a brain-computer interface (BCI) with functional electrical stimulation (FES) is feasible for motor learning in a 43-year-old woman who was 10 months post-stroke, leading to significant improvements in her ability to control finger movements.

After nine training sessions, the participant achieved volitional control of isolated index finger extension, indicating that this combined approach may effectively aid in motor recovery after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a new application of noninvasive Brain Computer Interface (BCI): a case study of training for recovery of volitional motor control after stroke. Daly, JJ., Cheng, R., Rogers, J., et al.[2016]

In a study involving 10 stroke patients, those using brain-computer interface-based functional electrical stimulation (BCI-FES) showed significant improvements in brain activation compared to those using standard functional electrical stimulation (FES).

The BCI-FES group exhibited notable changes in attention and activation indexes in specific brain regions, indicating that this method may enhance rehabilitation outcomes more effectively than traditional FES alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of brain-computer interface-based functional electrical stimulation on brain activation in stroke patients: a pilot randomized controlled trial. Chung, E., Kim, JH., Park, DS., et al.[2022]

The recoveriX system is a novel brain-computer interface designed specifically for stroke patients, aiming to enhance therapy by monitoring motor imagery in real-time.

Initial results from a single patient indicate that recoveriX can provide closed-loop feedback, potentially improving compliance and effectiveness of rehabilitation therapies for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

recoveriX: a new BCI-based technology for persons with stroke. Irimia, D., Sabathiel, N., Ortner, R., et al.[2020]

Brain-computer interface (BCI) training significantly improves motor function recovery in stroke patients, with a standardized mean difference (SMD) of 0.39 for upper extremity recovery and 0.41 for lower extremity recovery compared to conventional therapy alone, based on a meta-analysis of 14 studies involving 362 patients.

BCI training also enhances brain function recovery, showing a strong effect with an SMD of 1.11, indicating its potential as a valuable addition to rehabilitation strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. Kruse, A., Suica, Z., Taeymans, J., et al.[2020]

The recoveriX system, which integrates a brain-computer interface with functional electrical stimulation and visual feedback, was tested on two chronic stroke patients, showing promising results in motor rehabilitation.

After 10 training sessions, one patient regained partial control of wrist extension, while the other improved finger movement, indicating the system's potential for enhancing motor recovery in paralyzed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces With Multi-Sensory Feedback for Stroke Rehabilitation: A Case Study. Irimia, DC., Cho, W., Ortner, R., et al.[2018]

The study involved 10 healthy subjects and 5 stroke patients, revealing that stroke-affected EEG data has lower classification accuracy compared to healthy data, indicating challenges in designing effective BCIs for stroke rehabilitation.

Training a BCI using early stroke EEG data improved classification accuracy for later sessions, suggesting that individualized BCI training could enhance motor recovery by adapting to each patient's unique neuroplastic changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of EEG features during recovery following stroke - implications for BCI-mediated neurorehabilitation therapy. Leamy, DJ., Kocijan, J., Domijan, K., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic effects of brain-computer interface-controlled functional electrical stimulation training on balance and gait performance for stroke: A pilot randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a new application of noninvasive Brain Computer Interface (BCI): a case study of training for recovery of volitional motor control after stroke. [2016]

3. Japan pubmed.ncbi.nlm.nih.gov

Effects of brain-computer interface-based functional electrical stimulation on brain activation in stroke patients: a pilot randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

recoveriX: a new BCI-based technology for persons with stroke. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces With Multi-Sensory Feedback for Stroke Rehabilitation: A Case Study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

An exploration of EEG features during recovery following stroke - implications for BCI-mediated neurorehabilitation therapy. [2021]