Brain Stimulation for Stroke Recovery

Overseen By Radiology Studies

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Infectious diseases, Oral lesions, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8-10 weeks

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two non-invasive techniques can enhance recovery after a stroke. One method, BCI-FES (Brain-Computer Interface-Controlled Functional Electrical Stimulation), stimulates arm muscles, while the other uses the tongue to send signals to the brain. Participants include individuals with ongoing arm movement issues due to a stroke, those at risk of stroke, and healthy individuals. The researchers hope to discover if these new methods surpass current treatments in effectiveness. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could lead to new stroke recovery methods.

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 prior data suggests that these brain stimulation techniques are safe for stroke recovery?

Research has shown that both BCI-FES and RecoveriX treatments are safe for stroke survivors. Studies on BCI-FES indicate it can improve arm movement without major side effects. Similarly, RecoveriX has proven effective and safe, with no serious safety issues reported. Both treatments use the brain's signals to activate muscles and restore movement. Patients have tolerated these methods well, suggesting they are safe options for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for stroke recovery because they combine brain-computer interface (BCI) and functional electrical stimulation (FES) in innovative ways. Unlike traditional physical therapy, which often relies on repetitive movement exercises, BCI-FES and RecoveriX directly engage the brain's neural pathways. BCI-FES uses a closed-loop EEG system to help retrain the brain by linking thought to movement, potentially speeding up recovery. RecoveriX takes this a step further by merging virtual reality with BCI technology, creating a fully immersive rehabilitation experience. These approaches offer hope for more effective and faster recovery compared to standard therapies.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research has shown that BCI-FES, which combines brain-computer interface technology with electrical stimulation, can aid stroke recovery by improving arm movement. Studies indicate that it provides immediate benefits for stroke survivors, enhancing arm mobility. Some participants in this trial will receive immediate BCI therapy, while others will receive delayed BCI therapy, both aiming to assess the effectiveness of BCI-FES in stroke recovery.

RecoveriX, another brain-computer interface system under study in this trial, has shown promising results in improving movement and reducing muscle stiffness in stroke patients. In one study, 51 participants experienced significant improvements in arm movement. This suggests that RecoveriX may effectively aid stroke recovery by enhancing arm function. ^{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 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

I was independent in daily activities before my stroke.

No known neurologic, psychiatric or developmental disability

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• BCI-FES
• RecoveriX

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.

How Is the Trial Designed?

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+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0361923025001662

Advances in brain-computer interface controlled functional ... This paper reviews the application of BCI-FES in the recovery of upper limb function after stroke and explores its underlying mechanisms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11464471/

The effect of brain-computer interface controlled functional ... BCI-FES has significant immediate effects on upper limb function in subacute and chronic stroke patients, but evidence for its long-term impact remains limited.

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/1743-0003-8-49

Brain-Computer Interface Controlled Functional Electrical ... We describe the first successful integration of a noninvasive electroencephalogram (EEG)-based BCI with a noninvasive functional electrical stimulation (FES) ...

4. nature.com nature.com/articles/s41467-018-04673-z

Brain-actuated functional electrical stimulation elicits ... Here we show that BCI coupled to functional electrical stimulation (FES) elicits significant, clinically relevant, and lasting motor recovery in chronic stroke ...

5. research.aota.org research.aota.org/ajot/article/71/4_Supplement_1/7111515250p1/7397/Brain-Computer-Interface-With-Functional

Brain–Computer Interface With Functional Electrical ... Data suggest BCI–FES therapy is promising for UE rehabilitation poststroke. Primary Author and Speaker: Samantha Evander Elmore. Additional ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922947/

Efficacy and safety of brain–computer interface for stroke ... It has been proven that BCI-combined treatment can improve upper limb motor function and the quality of daily life for stroke patients.

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1438095/full

The effect of brain-computer interface controlled functional ... This review aims to evaluate the effectiveness of BCI-FES training on upper limb functional recovery in stroke patients.

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

A single-center, assessor-blinded, randomized controlled ... This Phase II clinical trial is a two-arm, randomized, controlled, longitudinal study with 66 stroke participants in the chronic (> 6 months) stage of gait ...