Optimization of Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as a Neurorehabilitation Tool
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in Fugl-Meyer Assessment of the Upper Extremity
Study Overview
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 with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)
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 treatment, it is critical to develop and refine a closed-loop taVNS platform that delivers stimulation concurrently during specific movements of the motor rehabilitation training.
Aim 1 develops this novel motion-gated closed-loop system that delivers taVNS in synchrony with specific upper limb motor activation (n=5) Aim 2 will combine the development of the closed-loop system with the investigator's mechanistic understanding to explore an open-label pilot trial (n=20) using closed-loop taVNS paired with task-specific training to determine the feasibility, safety, and potential effect size of this novel combination therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Change in Fugl-Meyer Assessment of the Upper Extremity
Time Frame: Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability.
Secondary Outcomes
No secondary outcomes reported
Investigators
Bashar Badran
Assistant Professor
Medical University of South Carolina