Recruiting

Vagus Nerve Stimulation

Sponsor:

MGH Institute of Health Professions

Code:

NCT07922200

Conditions

Stroke, Ischemic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vagus Nerve Stimulator

Study Details

Brief summary:

Paired Vagus Nerve Stimulation (VNS) has been shown to enhance upper extremity motor recovery after ischemic stroke. Prior studies have focused primarily on long-term clinical outcomes, leaving the short-term physiologic response to the intervention poorly understood. The purpose of this study is to examine real-time responses to Vagus Nerve Stimulation (VNS) in individuals with chronic motor impairments after ischemic stroke to better inform Paired VNS dosing. We plan to enroll 50 participants into a single-arm study and perform neurophysiologic assessments during VNS to identify objective markers of stimulation response and examine dose-response relationships.

Conditions

Stroke, Ischemic

Study ID

NCT07922200

Start date

Mar 26, 2026

Status verified date

Nov, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 80 years old
2. Implanted with VNS device for post-stroke motor rehabilitation
3. Ability to follow simple commands in English

Exclusion Criteria:

1. Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability
2. Visual or auditory disorders limiting ability to participate in study procedures
3. Evidence of an uncontrolled seizure disorder
4. Patients for whom EEG leads are contraindicated
5. Pregnancy

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vagus Nerve Stimulation (VNS)

VNS applied to the left vagus nerve at a range of stimulation parameters

Interventions

Vagus Nerve Stimulator

All participants enrolled in the study will receive stimulation across a range of intensities. (Minimum intensity = 0.0 mA, Maximum Intensity = 1.6 mA).

Primary outcome measure

  • Stimulation Intensity Eliciting Peak Change in Pupil Size [ Time Frame: Baseline, Throughout Each Stimulation Block (approx 3 minutes) ]

Central Contacts and Locations

Central contacts

Brain Recovery Lab Manager

617-643-6564brainrecoverylab@mghihp.edu

Teresa Kimberley, PhD, PT

(617) 643-9237tkimberley@mghihp.edu

Locations

MGH Institute of Health Professions

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Matthew Picard-Fraser, PT, DPT

617-643-6564brainrecoverylab@mghihp.edu

More Information

Sponsor

MGH Institute of Health Professions

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • Ischemic Stroke
  • Stroke
  • Vagus Nerve Stimulation
  • Pupillometry
  • Electroencephalography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by MGH Institute of Health Professions on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.