RECRUITING

Paired Vagus Nerve Stimulation Mechanisms

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanisms of Paired Vagus Nerve Stimulation (VNS) in Chronic Stroke: a Randomized, Blinded, Sham-controlled, Single-center Mechanistic Trial

Quick Facts

Study Start:2025-07-11

Study Completion:2029-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06716112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Heidi Schambra

CONTACT

929-455-5128

Heidi.schambra@nyulangone.org

Principal Investigator

Heidi Schambra, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

The University of Texas at Dallas

Richardson, Texas, 75080

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Heidi Schambra, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-11

Study Completion Date2029-09

Study Record Updates

Study Start Date2025-07-11

Study Completion Date2029-09

Terms related to this study

Additional Relevant MeSH Terms

Chronic Stroke