Actively Recruiting
Non-invasive VNS in Stroke Recovery
Led by The Methodist Hospital Research Institute · Updated on 2026-03-02
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of non-invasive trans-auricular vagus nerve stimulation taVNS combined with occupational therapy to improve motor recovery in adults who have had ischemic or hemorrhagic strokes at least six months earlier. The study aims to determine if taVNS provides greater clinical benefits than sham stimulation and to explore brain connectivity changes linked to motor function improvement using EEG and fMRI. This research seeks to better understand how taVNS may promote brain plasticity in stroke survivors. Participants will receive either active taVNS or sham stimulation during occupational therapy tasks for six weeks in a double-masked, randomized design. The active stimulation involves delivering weak electrical pulses through surface electrodes for up to 90 minutes per session, adjusted to create a well-tolerated skin sensation. After the initial phase, participants in the sham group can cross over to receive active taVNS, followed by an open-label home extension phase with continued taVNS and therapy to assess additional motor function gains and satisfaction. During the study, participants will undergo multiple assessments including motor function tests like the upper extremity Fugl-Meyer test, Wolf Motor Function Test, and various scales measuring stroke impact, spasticity, and depressive symptoms. Brain connectivity will be evaluated using EEG and fMRI at baseline, post-intervention, and follow-up timepoints. Researchers will monitor safety and collect feedback through questionnaires, with study visits occurring up to 18 weeks from baseline to track lasting effects and brain network changes associated with treatment.
CONDITIONS
Brief Title
Non-invasive VNS in Stroke Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic ischemic or hemorrhagic stroke confirmed by imaging causing arm weakness (MRC score 1-4)
- Age over 18 years, any gender, all racial and ethnic groups
- Stroke occurred more than 6 months before enrollment
- Able to safely undergo trans-auricular vagus nerve stimulation (taVNS)
- Able to follow two-step commands
- Modified Ashworth Scale score of 3 or less in the affected upper limb
- Passive range of motion within functional limits at shoulder, elbow, wrist, and hand
- Upper extremity Fugl-Meyer score of 60 or less (scale 0-66)
You will not qualify if you...
- History of severe alcohol or drug abuse, severe depression, poor motivation, serious language problems, or major cognitive impairments
- Bilateral weakness or sensory problems due to peripheral nerve or muscle injury
- Contraindications to brain MRI
- Severe uncontrolled medical conditions such as advanced heart, lung, kidney diseases, active cancer, epilepsy, or severe arthritis
- Unstable heart rhythm issues like arrhythmia or reentry tachycardia
- Pregnancy
- Presence of pacemakers, stimulators, or other devices that interfere with stimulation
- Non-English speakers without access to a translator for all study sessions until funding is available for translation services
Research Team
D
Darrel W Cleere, MPH
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