A device for stroke rehabilitation using brain and muscle stimulation
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
This study is testing a new device that uses brain and muscle stimulation to see if it can help stroke patients recover better than traditional rehab methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT02098265 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult stroke patients with persistent upper extremity deficits.
Not a fit: Patients with no upper extremity impairments or those with certain neurological or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for stroke patients with upper extremity impairments.
How similar studies have performed: Other studies have shown promise with similar non-invasive stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madison, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.