Paired Vagus Nerve Stimulation Mechanisms
Not Applicable
Not yet recruiting
- Conditions
- Registration Number
- NCT06716112
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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 ...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Percent change in Ipsilesional CST MEP Size after Active VNS Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2]) Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.
Percent change in Ipsilesional CST MEP Size after Sham VNS Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1]) Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.
- Secondary Outcome Measures
Name Time Method Percent change in Ipsilesional CReST MEP Size after Active VNS Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2]) Ipsilesional corticoreticulospinal tract (CReST) motor evoked potential (MEP) size measured before and after the treatment block.
Percent change in Ipsilesional CReST MEP Size after Sham VNS Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1]) Ipsilesional corticoreticulospinal tract (CReST) motor evoked potential (MEP) size measured before and after the treatment block.
Percent Change in Wrist Strength after Active VNS Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2]) Percent Change in Wrist Strength after Sham VNS Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1]) Percent Change in Motor Control after Active VNS Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2]) Percent Change in Motor Control after Sham VNS Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1]) Percent Change in Individuation after Active VNS Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2]) Percent Change in Individuation after Sham VNS Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States