Status:
COMPLETED
taVNS for Upper Limb Rehabilitation
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently...
Detailed Description
This study aims to refine and develop closed loop taVNS, establish activity with key biomarkers, and show initial feasibility in a small clinical trial. For paired taVNS to succeed as a clinical treat...
Eligibility Criteria
Inclusion
- 18-80 years old
- Ischemic or hemorrhagic stroke that occurred at least 6 months prior
- Completed conventional rehabilitation therapy at least one month prior
- Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than or equal to 58 (out of 66)
Exclusion
- Primary intracerebral hematoma, or subarachnoid hemorrhage
- Bilateral upper extremity weakness
- Other concomitant neurological disorders affecting upper extremity motor function
- Documented history of dementia before or after stroke
- Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment
- Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) \>=180/100mmHg at baseline
- Contraindicated for MRI scanning.
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04129242
Start Date
February 19 2020
End Date
October 5 2022
Last Update
February 28 2024
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425