Non-invasive VNS in Stroke Recovery

NCT06761404 | Recruiting FDA Device

• 1 other identifier: PRO00038365
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery

Conditions

Stroke

Keywords

taVNS; trans-auricular; non-invasive vagus nerve stimulation; stroke recovery; neuromodulation; rehabilitation; chronic stroke

Outcome Measures

Primary Outcomes (1)

• To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery

  To determine the extent to which taVNS with concurrent occupational therapy (OT), causes significant, lasting motor gains in chronic stroke population Upper extremity Fugl-Meyer (uFM) The uFM test measures both proximal and distal upper extremity movements, ranges 0-66, higher score is better.

  [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]

Secondary Outcomes (16)

• To evaluate the biomarkers of plasticity associated with VNS

  [Time Frame: Baseline 1(week 1), post-intervention (week 6), post intervention for sham crossover only (week 12)]

• Wolf Motor Function Test (WMFT)

  [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]

• Functional upper extremity levels (FUEL)

  [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]

• NIH STROKE SCALE (NIHSS)

  [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Max score 42, minimum score 0. Score of 0 is best outcome

• MRC grading scale

  [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)]. Minimum score 0, max score 5 per item. 5 is normal, 0 is no movement.

Study Arms (2)

Sham Stimulation

SHAM COMPARATOR

Same procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions..

Device: taVNS

taVNS

EXPERIMENTAL

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.

Device: taVNS

Interventions

taVNS DEVICE

Experimental. The current will be increased gradually for both sham and real stimulation at the beginning of the 90-minute stimulation to lessen the itchy/numb skin sensation and to create the same skin sensation for subject blinding.

Sham Stimulation; taVNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as unable to follow study instructions).
• Patients with bilateral paresis, or weakness or sensory damage due to peripheral causes (e.g. peripheral nerve injury, muscle or orthopedic injury etc.)
• Subjects with contraindication to MRI of the brain
• Patients with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, epilepsy or others).
• Patients with unstable cardiac arrhythmia, reentry tachycardia.
• Pregnancy
• Patients with pacemakers or stimulators that interfere with the stimulation, or other investigational devices or drugs
• Non-English speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However we plan to include them once funding has been secured in the subsequent larger trial.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Timea Hodics, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrel W Cleere, MPH

CONTACT

7134413770; dwcleere@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Neuro-Recovery Program

Model Details: Sham stimulation vs taVNS

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 7, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)