This trial is examining a new treatment involving nerve stimulation for stroke survivors with arm/hand paralysis. The main outcome to be measured will be the change in wrist movement. This study is being conducted in New York, US.
The details
Stroke is the fifth leading cause of death in the US. A common side effect of stroke is weakness or paralysis in the arms/legs. These complications affect the daily life of stroke survivors and their quality of life.
Prior studies suggested that rehabilitation with robotic arm/hands is associated with positive treatment outcomes. Combining this with a non-invasive brain, nerve, and spinal electric stimulation might increase the response to the treatment. This stimulation consists of a very low level of constant current being delivered to specific areas of the brain.
This trial is examining a new treatment involving nerve stimulation for stroke survivors with arm/hand paralysis. The main outcome to be measured will be the change in wrist movement.
Who are they looking for?
This trial is recruiting 44 stroke survivors with arm/hand paralysis. Participants must understand the experiments and follow instructions and have a healthy body weight.
Participants must not have received botox or phenol treatment within 3 months before this trial. Patients must not have a complete paralysis of the affected wrist, must not participate in another experimental study, must not be pregnant or breastfeeding. Patients must not have had a thalamic stroke, prior surgery for arm paralysis, history of spinal cord injury. Patients must not have chronic pain, diabetes or ongoing use of medications for paralysis. These patients must also not have damaged skin at the site of stimulation or a body medical device (such as a pacemaker). Any highly conductive metal in the body is also not recommended.
How will it work
Participants will be assigned to receive either stimulation and robotic wrist therapy or robotic wrist therapy alone. Patients in the stimulation group will receive 2 doses of 5 days of 20-minute stimulation combined with 6 weeks of robotic therapy (3 times a week). Patients in the robotic therapy alone group will receive placebo stimulation (with no effect on the body) combined with 6 weeks of robotic therapy (3 times a week).
A change in muscle tone is evaluated at discharge and after 4 weeks.
