Actively Recruiting
Paired Vagus Nerve Stimulation Mechanisms
Led by NYU Langone Health · Updated on 2025-07-17
40
Participants Needed
2
Research Sites
215 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this mechanistic study, 40 individuals with chronic stroke will be implanted with a small vagus nerve stimulation (VNS) device. The study will use a randomized, blinded, crossover design to deliver two conditions in six-week blocks: active VNS or sham VNS, each paired with upper extremity (UE) motor rehabilitation. Assessment visits will occur before and after each block, and will examine neural pathway strength, functional connectivity, and motor and non-motor behaviors. Investigators will test for VNS-induced changes in motor, cognitive, and affective systems, and will identify biomarkers predictive of clinical response.
CONDITIONS
Official Title
Paired Vagus Nerve Stimulation Mechanisms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed and dated informed consent
- Willing to comply with all study procedures and available for the study duration
- Aged between 22 and 79 years
- Have unilateral supratentorial ischemic stroke occurred at least 12 months before enrollment
- Upper extremity Fugl-Meyer Assessment score between 20 and 50
- Modified Rankin Score of 2, 3, or 4
- Meet all clinical criteria for VNS implantation as determined by the principal investigator and clinical care team
You will not qualify if you...
- Intracerebral hemorrhage or traumatic brain injury
- Language or attention deficits interfering with study participation
- Severe spasticity (Modified Ashworth score above 3)
- Psychiatric disorders or cognitive impairments interfering with participation
- Receiving therapies interfering with VNS, including drugs affecting neurotransmitters
- Presence of any other implanted electrical stimulation device
- Prior injury to the vagus nerve
- Females of childbearing potential who are pregnant, lactating, heterosexually active, or planning pregnancy, and not using approved birth control methods
- Concurrent participation in another interventional clinical trial
- Presence of ferromagnetic metal in head (except dental work) or torso
- Current or past medical or non-medical conditions posing risk or interfering with study completion, including renal, cardiac, endocrine, immunologic, psychiatric, neurologic, or swallowing disorders
- Neck circumference larger than 18.5 inches
- Current incarceration or legal detention as determined by the principal investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
The University of Texas at Dallas
Richardson, Texas, United States, 75080
Actively Recruiting
Research Team
H
Heidi Schambra
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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