Vagus nerve stimulation paired with arm rehabilitation to improve recovery after chronic stroke
Mechanisms of Paired Vagus Nerve Stimulation (VNS) in Chronic Stroke: a Randomized, Blinded, Sham-controlled, Single-center Mechanistic Trial
This project will test whether implanting a small vagus nerve stimulator and pairing active stimulation with arm rehabilitation helps people with chronic stroke improve movement, thinking, and mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 22 Years to 79 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06716112 on ClinicalTrials.gov |
What this trial studies
Forty people with chronic ischemic stroke will be implanted with a small vagus nerve stimulation (VNS) device and participate in a randomized, blinded, crossover protocol. Each participant will complete two six-week blocks—active VNS plus upper-extremity rehabilitation and sham VNS plus the same rehabilitation—with assessments before and after each block. Outcomes include measures of neural pathway strength, functional connectivity, motor performance, and non-motor (cognitive and affective) behaviors. The study will also search for biomarkers that predict which patients respond best to VNS-paired rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are adults 22–79 years old with a single supratentorial ischemic stroke at least 12 months earlier, moderate arm impairment (Fugl-Meyer 20–50), modified Rankin Score 2–4, medically eligible for VNS implantation, able to provide consent, and able to attend study visits.
Not a fit: People with intracerebral hemorrhage or traumatic brain injury, severe spasticity, language or attention deficits that prevent participation, significant psychiatric or cognitive impairment, or who take medications that interfere with VNS are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, pairing VNS with arm rehabilitation could improve arm movement and related cognitive and emotional outcomes for some people with chronic stroke and help identify who is likely to benefit.
How similar studies have performed: Previous pilot and randomized studies of VNS paired with rehabilitation have shown promising motor improvements, but the mechanisms and predictors of response are still being defined.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Ability to provide signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* 22-79 years of age
* Unilateral supratentorial ischemic stroke that occurred ≥ 12 months prior to enrollment
* Upper extremity Fugl-Meyer Assessment score of 20 to 50
* Modified Rankin Score of 2, 3, or 4
* Meets all clinical criteria for VNS implantation as determined by the PI and clinical care team
Exclusion Criteria:
* Intracerebral hemorrhage or traumatic brain injury
* Deficits in language or attention that interfere with study participation
* Severe spasticity (Modified Ashworth \> 3)
* Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
* Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
* Presence of any other implanted electrical stimulation device
* Prior injury to vagus nerve
* Females of childbearing potential who are either pregnant, lactating, heterosexually active, or planning to become pregnant or heterosexually active during study participation; and who are not using, or will not agree to use, the following medically acceptable birth control methods:\* (1) sterilization surgery for women, (2) Surgical Sterilization Implant for Women, (3) sterilization surgery for men, (4) long-acting reversible contraceptives (LARC) - implantable rod and IUD; (5) contraceptive shot/injection every 3 months; (6) oral contraceptives ("The Pill"); (7) contraceptive patch; and (8) vaginal contraceptive ring.
* Concurrent participation in another interventional clinical trial
* Ferromagnetic metal in head (except dental work) or torso
* Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability\*; or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation: may pose a significant or undue risk to the person; make it unlikely the person will complete all the study requirements per protocol; or may adversely impact the integrity of the data or the validity of the study results. \[\*Examples include, but are not limited to, the following types of conditions, diseases or disorders: renal, peripheral vascular, cardiac, endocrinologic (e.g., diabetes), immunologic, psychiatric (e.g., substance use), neurologic (e.g., cognitive), or dysphagia\]
* Persons with a neck circumference larger than 18.5 inches
* As determined by the principal investigator, is under current incarceration or legal detention
Where this trial is running
New York, New York and 1 other locations
- NYU Langone Health — New York, New York, United States (Recruiting)
- The University of Texas at Dallas — Richardson, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Heidi Schambra, MD — NYU Langone Health
- Study coordinator: Heidi Schambra
- Email: Heidi.schambra@nyulangone.org
- Phone: 929-455-5128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.