IRB Study Number 19-286
Status Recruiting
Phase Not Applicable
Locations Cleveland Clinic Main Campus, N Building - Education Building and Lerner Research Institute
Institute Lerner Research Institute
Description
The purpose of this study is to test whether the combination of a unique rehabilitation therapy, called contralaterally controlled functional electrical stimulation (CCFES), and a new non-invasive brain stimulation (rTMS) produces improvements in arm and hand function.
Contralaterally controlled functional electrical stimulation (CCFES) is an investigational (experimental) technique that uses electrical stimulation to open the weak hand. Sticky patches called electrodes are placed on the participant’s weak arm to stimulate the hand muscles, and a special glove is worn on the strong hand and controls the stimulator. When the patient opens their gloved hand, stimulation opens the weak hand; when the patient closes their gloved hand, stimulation turns off and the weak hand relaxes.
Brain stimulation will be given using a non-invasive technique known as repetitive Transcranial Magnetic Stimulation (rTMS). RTMS is an experimental approach of targeting the brain to promote hand function. Specific parts of the brain devoted to moving the weak hand are targeted with currents delivered from over the scalp and skull without requiring surgery. An electrical current is passed through the coil and it creates a magnetic field that is focused on the area of brain that controls your hand.
Study participation is for a total of 9 months and includes three months of rehabilitation therapy. You will be compensated for completion of the study including travel reimbursement.
Inclusion Criteria
- 18-90 years old
- Suffered a stroke more than 6 months ago
- Limited movement of hand and/or wrist
- Ability to lift hand from side to lap without assistance
Exclusion Criteria
- History of epilepsy
- Metal in the head or neck
- Implantable devices such as pacemaker
- Severe neglect or loss of sensation in affect arm/hand
- Currently taking the medication Wellbutrin
