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Brain-Computer Interface

BCI Technology for Stroke Rehabilitation

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

Right hand dominant - affected arm

Mild to moderate unilateral upper extremity impairment or severe unilateral upper extremity impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial will test if electrical brain signals can help improve movement and function after a stroke.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects may include discomfort from EEG cap use, skin irritation from electrodes during FES therapy, temporary fatigue following exercises, and rare risks associated with MRI such as reactions to contrast material.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Action Research Arm Test Scores

Stroke Impact Scale

Secondary outcome measures

Blood coagulation tests

Change in Electroencephalogram (EEG) Response Strength

Change in Hand Grip Strength

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active FESExperimental Treatment4 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 FESActive Control3 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,187 Previous Clinical Trials

3,169,353 Total Patients Enrolled

13 Trials studying Stroke

270,976 Patients Enrolled for Stroke

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

649,215 Total Patients Enrolled

171 Trials studying Stroke

83,714 Patients Enrolled for Stroke

Vivek Prabhakaran, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

1 Previous Clinical Trials

288 Total Patients Enrolled

1 Trials studying Stroke

288 Patients Enrolled for Stroke

Media Library

Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology (Brain-Computer Interface) Clinical Trial Eligibility Overview. Trial Name: NCT04141774 — N/A

Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology (Brain-Computer Interface) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04141774 — N/A

Stroke Clinical Trial 2023: Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology Highlights & Side Effects. Trial Name: NCT04141774 — N/A

Stroke Research Study Groups: Active FES, Passive FES

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes does this research endeavor hope to accomplish?

"The primary indicator of success monitored over the four-month duration is the Stroke Impact Scale. Secondary objectives include tracking changes in patients' Modified Ashworth Scale, Center for Epidemiological Studies Depression Scale, and Nine Hole Peg Test scores at various intervals throughout this trial."

Answered by AI

Does this exploration currently invite patient participation?

"Affirmative. According to the data posted on clinicaltrials.gov, this experiment is still recruiting participants since it was first published in September of 2018 and last updated during August 2022. This trial needs 144 patients from a single medical facility."

Answered by AI

Are individuals over 35 eligible to participate in this research?

"This trial is searching for participants in the age range of 50 to 85. Meanwhile, there are 37 trials targeting people below 18 years old and 1007 studies enrolling individuals above 65."

Answered by AI