What side effects are associated with this type of intervention?

Muscle Stimulation of the Arm (Direct Muscle Activation) and Neuro-Stimulation through the Tongue (Neural Pathway Stimulation) are non-invasive techniques being studied for stroke recovery. Common side effects of similar non-invasive brain stimulation treatments can include mild discomfort at the stimulation site, skin irritation, headache, dizziness, and fatigue. These side effects are generally temporary and resolve shortly after the treatment session.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, primarily focusing on thrombolytic agents like tissue plasminogen activator (tPA) for acute ischemic stroke. However, specific treatments involving muscle stimulation of the arm (direct muscle activation) and neuro-stimulation through the tongue (neural pathway stimulation) are still under investigation. These non-invasive brain stimulation techniques aim to enhance stroke recovery by promoting neural plasticity and functional improvements, but they have not yet received FDA approval. Current research, including clinical trials, is ongoing to evaluate their efficacy and safety.

What other types of research exist?

Promising novel alternatives for stroke rehabilitation in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in various neurological conditions including stroke recovery by modulating cortical activity. 2) Vagus Nerve Stimulation (VNS), which has been explored for its neuroplasticity-enhancing effects that could aid in stroke recovery. Both techniques are non-invasive and have shown promise in clinical trials for other neurological conditions.

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Neurostimulation Device

Brain Stimulation for Stroke Recovery

N/A

Recruiting

Led By Vivek Prabhakaran, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.

Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45)

Must not have

Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the electrical stimulation or wearing of electrodes and possible skin irritation from electrode gels or tapes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was independent in daily activities before my stroke.

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My right hand has moderate impairment due to a stroke.

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I had no arm or hand injuries or conditions before my stroke.

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I have lasting arm weakness from a stroke.

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I had a stroke but do not have arm or hand problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently being treated for any infectious diseases and do not have any visible mouth sores or inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Action Research Arm Test Scores

Secondary study objectives

Change in Electroencephalogram (EEG) Response Strength

Signal change in functional MRI

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group - RecoveriXExperimental Treatment1 Intervention

Recruited from participants who have completed the study intervention

Group II: Experimental Group - Immediate BCI TherapyExperimental Treatment4 Interventions

EEG - BCI training (closed loop)

Group III: Experimental Group - Delayed BCI TherapyExperimental Treatment5 Interventions

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

Group IV: Control Group 1Active Control4 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 2Active Control1 Intervention

24 Stroke Patients with UE impairment receiving standard FES only therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BCI-FES

2013

N/A

~20

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Muscle stimulation of the arm, or direct muscle activation, works by electrically stimulating the muscles to promote movement and strength, which can help in regaining motor function lost due to stroke. This method aims to enhance muscle re-education and prevent atrophy. Neuro-stimulation through the tongue, or neural pathway stimulation, involves stimulating the cranial nerves to promote neuroplasticity and improve brain function. This can help in re-establishing neural connections that were damaged during the stroke. Both treatments are non-invasive and aim to accelerate recovery by leveraging the body's natural ability to heal and adapt, which is crucial for improving the quality of life and functional independence of stroke patients.