Paired Vagus Nerve Stimulation Mechanisms

Launched by NYU LANGONE HEALTH · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a small device that stimulates the vagus nerve in people who have had a stroke more than a year ago. The aim is to see if this stimulation can help improve movement, thinking, and emotional responses in individuals with chronic stroke. The trial will involve 40 participants who will receive either the active device or a placebo (a device that does nothing) in alternating six-week periods, along with rehabilitation exercises for their arms. Throughout the study, researchers will monitor changes in brain activity and other health markers to see how the treatment works.

To be eligible for this trial, participants should be between 22 and 79 years old and have experienced a specific type of stroke that has affected one side of their body. They should also be willing to follow study procedures and have a certain level of movement ability in their arms. However, some individuals may not qualify, such as those with certain medical conditions, severe muscle stiffness, or those who are pregnant. Participants can expect regular visits to assess their progress and to help understand how well the treatment is working. It’s important for anyone interested to discuss with their healthcare provider to see if they meet the requirements and if this study is a suitable option for them.

Gender

ALL

Eligibility 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
• • Appropriate surgical candidate for VNS electrode implantation
• Exclusion Criteria:
• • Subarachnoid or intraventricular 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. \[\*Examples include, but are not limited to, the following types of conditions, diseases or disorders: renal, peripheral vascular, cardiac, endocrinologic (e.g., diabetes), immunologic, psychiatric (e.g., substance use), neurologic (e.g., cognitive), or dysphagia\]
• • Non-English speaking
• • As determined by the principal investigator, is under current incarceration or legal detention