Early Phase 1
N=20
taVNS for Upper Limb Rehabilitation
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04129242 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Fugl-Meyer Assessment of the Upper Extremity — 5; 3.14 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fugl-Meyer Assessment of the Upper Extremity |
5; 3.14 | — |
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)
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04129242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.