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Stroke Rehabilitation with FES and RecoveriX

This study is testing if two non-invasive (not entering the body) brain stimulation techniques can improve stroke recovery. These techniques are Functional Electric Stimulation (FES), which uses electrical pulses to move muscles, and neuro-stimulation through the tongue. The study also uses RecoveriX, a brain-driven rehabilitation system that connects mental activities with movement. Researchers want to see if these methods, guided by brain activity measured with EEG (electroencephalogram), can improve arm movement and change brain activity, as seen on fMRI (functional magnetic resonance imaging) scans. You may be able to join if you are an adult stroke patient with ongoing arm weakness. The study aims to enroll 288 participants.

Study design
This interventional study plans to enroll 288 participants, including stroke patients with arm weakness, stroke patients without arm weakness, and healthy controls. Participants in the experimental group will be randomly assigned to receive either BCI (brain-computer interface) training with muscle and tongue stimulation or traditional rehabilitation.
What's involved
Participants will undergo behavioral assessments, MRI scans, and EEG measurements. Some participants will receive 8-10 weeks of BCI-FES-tongue stimulation therapy, while others will receive 4-6 sessions of BCI system training.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Action Research Arm Test Scores, will be measured at 4 months.

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NCT02098265

A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Recruiting
NAAges 18+InterventionalTreatment
University of Wisconsin, Madison
~288 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Functional Electric Stimulation (FES)Behavioral AssessmentsMagnetic Resonance ImagingEEGRecoveriXDelay

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Action Research Arm Test Scores
Measured over 4 months

Conditions

Stroke

Explore related trials

AneurysmStrokeTransient Ischemic Attack

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Vivek Prabhakaran, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Radiology Studies
[email protected]
608-282-8349
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Stroke patients with persistent upper extremity (UE) deficits
Stroke patients without UE impairments
Participants with risk factors for stroke
healthy controls
No known neurologic, psychiatric or developmental disability
Stroke patients with persistent upper extremity (UE) deficits
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)
No upper extremity injury or conditions that limited use prior to the stroke
Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.

Exclusion

Allergic to electrode gel, surgical tape and metals
Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
Women who are pregnant or may become pregnant during the course of the study will be excluded
Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)
Contraindications for MRI
Allergic to electrode gel, surgical tape, and metals.

What this trial measures

  • Action Research Arm Test Scores4 months

    The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. ARAT will be assessed at baseline and end of study (approximately 4 months)