A device for stroke rehabilitation using brain and muscle stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate the effectiveness of a closed-loop rehabilitation device that combines functional muscle stimulation of the arm and non-invasive neurostimulation through the tongue, guided by EEG output, to enhance recovery in stroke patients. The study will involve adult stroke patients with upper extremity motor impairments, as well as healthy controls and individuals with stroke risk factors. Participants will be randomly assigned to receive either the innovative stimulation therapy or traditional rehabilitation methods, with outcomes measured through behavioral assessments and brain imaging techniques like fMRI.

Why it matters

Who can join: the full rules

Inclusion Criteria (Experimental Group):

* Stroke patients with persistent upper extremity (UE) deficits

Inclusion Criteria (Control Group 1)

* Stroke patients without UE impairments
* Participants with risk factors for stroke
* healthy controls

  * No known neurologic, psychiatric or developmental disability

Inclusion Criteria (Control Group 2)

* 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 Criteria (for all participants):

* 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)

Exclusion Criteria (for healthy controls)

* Contraindications for MRI
* Allergic to electrode gel, surgical tape, and metals.

Where it's running

• University of Wisconsin
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Vivek Prabhakaran, MD, PhD — University of Wisconsin, Madison
• Study coordinator: Radiology Studies
• Email: Radstudy@uwhealth.org
• Phone: 608-282-8349

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-task balance training plus computer-based cognitive training after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.