NCT02098265 · University of Wisconsin, Madison
A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
What this study is about
The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the treatment group$1 and neuro-stimulation through the tongue, can increase the extent of stroke recovery.
View original scientific description
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.
Interventions
DEVICE
Functional Electric Stimulation (FES)
FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.
BEHAVIORAL
Behavioral Assessments
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
OTHER
Magnetic Resonance Imaging
A functional magnetic resonance image will be collected.
OTHER
EEG
EEG electrodes will be attached to the participant's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.
OTHER
RecoveriX
RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.
OTHER
Delay
10 week delay before intervention
DEVICE
BCI-FES
Primary outcome measures
Action Research Arm Test Scores
Time frame: 4 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Madison, Wisconsin
Collaborators
American Heart Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations