Non-invasive VNS in Stroke Recovery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Symptomatic ischemic or hemorrhagic stroke verified by computerized axial tomography or magnetic resonance imaging resulting in hemiparesis (MRC 1-4).
• Age more than 18, Male or Female, All racial and ethnic groups
• Entry into the study \>6 months post onset
• Patients who can safely undergo taVNS
• Able to follow 2 step commands
• Modified Ashworth Scale Score =\<3 in the involved upper extremity
• Passive range of motion within functional ranges at the shoulder, elbow, wrist and hand
• UFM =\< 60 (scale 0-66)
Locations
United States
Texas
Houston Methodist Research Institute
RECRUITING
Houston
Contact Information
Primary
Darrel W Cleere, MPH
dwcleere@houstonmethodist.org
7134413770
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 60
Treatments
Sham_comparator: Sham Stimulation
Same procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions..
Experimental: taVNS
Weak current (up to 0.8-4 mA) will be delivered using pulses according to standard protocol during each motor task for up to 90-minutes through surface electrodes which will be administered using the intensity identified as resulting in well tolerated skin sensation and best motor performance during our initial testing session.
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute