This trial is examining the effectiveness of transcutaneous vagus nerve stimulation (TVNS) and robotic training to treat arm disability after stroke. The main outcome to be measured will be the change in muscle activity before and after treatment. This study is being conducted in New York, United States.
The details
Often patients present with arm disability after a stroke. This will decrease the ability to perform daily activities, affecting the quality of life of these patients. Prior studies showed that TVNS improves arm recovery after stroke. TVNS consists of a medical device that is located under the skin below the collarbone (by surgery). This device delivers electrical impulses to the vagus nerve (responsible for arm movement).
Another therapy that has been increasingly used to treat this disability is robotic therapy. This consists of using a robotic arm that helps to start the movement.
This trial is evaluating TVNS combined with robotic therapy affects the arm recovery of patients with stroke. The main outcome will be measured as the change in arm function before and after treatment.
Who are they looking for?
This trial will be recruiting 35 patients with stroke. Patients should have the mental ability to understand the treatment and follow instructions.
Patients should not have had a hemorrhagic stroke, botox treatment within 3 months of the start of this trial, prior injury in the vagus nerve or severe difficulty in swallowing. Patients should also not be pregnant or breastfeeding, should not have heart disease or another electrical medical device implanted. Patients taking psychiatric medications including anti-anxiety or antidepressive drugs will be excluded.
How will it work
There will be two groups in this study. Patients will receive TVNS or placebo (treatment with no effect on the body). All patients will receive robotic therapy. Treatments will be delivered for 60 minutes, 3 times per week for 3 weeks. The main outcome is the change in arm activity at a follow-up of 16 weeks after the treatment.
