A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
United States288 participantsStarted 2010-06
Plain-language summary
The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can increase the extent of stroke recovery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.