Brain-Computer Interface Training after Stroke Affects Patterns of Brain-Behavior Relationships in Corticospinal Motor Fibers.
Brittany M Young, Julie M Stamm, Jie Song...
https://pubmed.ncbi.nlm.nih.gov/27695404Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID02098265
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Led by University of Wisconsin, Madison · Updated on 2026-05-15
288
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining two non-invasive brain stimulation methods—muscle stimulation of the arm using functional electrical stimulation (FES) and neurostimulation through the tongue—can improve recovery after stroke. This study focuses on adults who have experienced a stroke and have upper extremity motor impairments, aiming to measure changes in motor function and brain plasticity using behavioral tests and functional MRI scans. Participants are divided into several groups including stroke patients with upper extremity impairments receiving EEG-guided brain-computer interface (BCI) training combined with muscle and tongue stimulation, stroke patients receiving traditional rehabilitation before starting BCI-FES-tongue therapy, stroke patients receiving standard FES therapy only, healthy controls, and people with stroke risk factors. The study involves training sessions with the EEG-BCI system, muscle and tongue stimulation, and the use of the recoveriX system, which provides real-time visual and tactile feedback paired with imagined hand movements. The intervention periods vary, with some groups receiving delayed therapy and others immediate BCI therapy. Participants will undergo multiple assessments including behavioral tests of upper extremity function, EEG recordings, and functional MRI scans at the start and after about four months of therapy. The researchers will monitor changes in arm function using the Action Research Arm Test and observe brain activity changes through EEG and fMRI. The study includes up to six BCI training sessions and regular evaluations over approximately 10 weeks, with some groups receiving additional follow-up MRI and behavioral testing. Safety screening excludes those with allergies to electrode materials or contraindications for MRI, and pregnant women are not eligible.
CONDITIONS
Brief Title
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Stroke patients with persistent upper extremity deficits (Experimental Group)
- Stroke patients without upper extremity impairments (Control Group 1)
- Participants with risk factors for stroke (Control Group 1)
- Healthy controls with no known neurologic, psychiatric, or developmental disability (Control Group 1)
- Stroke patients with moderate upper extremity impairment affecting the dominant right hand (NIHSS motor score 1 or 2 and ARAT score 20-45) (Control Group 2)
- No upper extremity injury or limiting conditions prior to stroke (Control Group 2)
- Pre-stroke independence with Modified Rankin Score of 0 or 1 (Control Group 2)
You will not qualify if you...
- Allergic to electrode gel, surgical tape, or metals
- Currently treated for infectious diseases or have oral lesions or inflammation
- Pregnant women or those who may become pregnant during the study
- Contraindications for MRI (participants without MRI eligibility may join intervention and behavioral testing only)
- Healthy controls with MRI contraindications or allergies to electrode gel, surgical tape, or metals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Training and Baseline Assessments
Duration - Up to 10 weeks depending on group assignment
Participants receive training on the EEG-BCI system and complete baseline behavioral testing and MRI scans before starting therapy.
4 training sessions and 2 behavioral testing sessions with MRI scans before therapy
Treatment
Duration - Approximately 8 to 10 weeks or longer depending on group assignment
Participants in the experimental groups receive EEG-BCI guided functional muscle stimulation therapy, including closed-loop brain-computer interface training paired with functional electrical stimulation and tongue neurostimulation.
Multiple therapy sessions including muscle and tongue stimulation; exact number varies by group
Treatment with RecoveriX System
Duration - Duration consistent with treatment period
A subgroup of participants receive brain-driven rehabilitation using the recoveriX system, combining EEG-based feedback with bilateral functional electrical stimulation.
Multiple therapy sessions with bilateral arm stimulation
Behavioral and Imaging Assessments
Duration - Throughout the study duration, particularly at baseline and 4 months
Participants undergo behavioral assessments and MRI scans to measure stroke recovery and brain plasticity before and after treatment.
At least 2 behavioral testing sessions and MRI scans
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53706
Actively Recruiting
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Research Team
R
Radiology Studies
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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Published Research Related To This Trial
Dose-response relationships using brain-computer interface technology impact stroke rehabilitation.
Brittany M Young, Zack Nigogosyan, Léo M Walton...
https://pubmed.ncbi.nlm.nih.gov/26157378DTI measures track and predict motor function outcomes in stroke rehabilitation utilizing BCI technology.
Jie Song, Veena A Nair, Brittany M Young...
https://pubmed.ncbi.nlm.nih.gov/25964753Characterizing relationships of DTI, fMRI, and motor recovery in stroke rehabilitation utilizing brain-computer interface technology.
Jie Song, Brittany M Young, Zack Nigogosyan...
https://pubmed.ncbi.nlm.nih.gov/25120466Case report: post-stroke interventional BCI rehabilitation in an individual with preexisting sensorineural disability.
Brittany M Young, Zack Nigogosyan, Veena A Nair...
https://pubmed.ncbi.nlm.nih.gov/25009491Ipsilesional Mu Rhythm Desynchronization and Changes in Motor Behavior Following Post Stroke BCI Intervention for Motor Rehabilitation.
Alexander B Remsik, Leroy Williams, Klevest Gjini...
https://pubmed.ncbi.nlm.nih.gov/30899211Behavioral Outcomes Following Brain-Computer Interface Intervention for Upper Extremity Rehabilitation in Stroke: A Randomized Controlled Trial.
Alexander B Remsik, Keith Dodd, Leroy Williams...
https://pubmed.ncbi.nlm.nih.gov/30467461