Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)

Completed · Not applicable

Conditions studied: Cerebrovascular Stroke, Upper Extremity Paresis

In brief

This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (\<30, \>30) and baseline FMA UE (20 to \<35; \>35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

Key facts

Study ID

NCT03131960

Run by

MicroTransponder Inc.

People needed

108

Starts

2017-07-01

Expected to finish

2022-06-30

Last updated by the study team

2022-07-20

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of unilateral supratentorial ischemic stroke that occurred at least 9 months but not more than ten 10 years prior to enrollment.
• Age >22 years and <80 years.
• FMA-UE score of 20 to 50 (inclusive of 20 and 50).
• Ability to communicate, understand, and give appropriate consent. Subjects should be able to follow two-step commands.
• Right- or left-sided weakness of upper extremity.
• Active wrist flexion/extension; active abduction/extension of thumb and at least two additional digits.

You may not qualify if…

• History of hemorrhagic stroke
• Presence of ongoing dysphagia or aspiration difficulties.
• Subject receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry. A list of excluded medications will be provided to Investigators.
• Prior injury to vagus nerve, either bilateral or unilateral (e.g., injury during carotid endarterectomy).
• Severe or worse depression (Beck Depression Scale > 29) (Beck et al., 1961)
• Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
• Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
• Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.
• Pregnancy or plans to become pregnant or to breastfeed during the study period.
• Current requirement, or likely future requirement, of diathermy during the study duration.
• Active rehabilitation within 4 weeks prior to consent.
• Botox injections or any other non-study active rehabilitation of the upper extremity within 4 weeks prior to therapy through the post-30 day visit (Visit 6).
• Severe spasticity of the upper limb (Modified Ashworth ≥3) (Bohannon and Smith, 1987).
• Significant sensory loss. Sensory loss will be measured using the Upper Extremity sensory section of the Fugl Meyer Assessment of Physical Performance. The assessment addresses light touch (2 items) and proprioception (4 items).The highest points attained is 12; subjects with scores less than 6 will be excluded from the study.

Where it is running

• Perseverance Research Center — Scottsdale, Arizona, United States
• Rancho Research Institute — Downey, California, United States
• Providence St. John's Medical Center — Santa Monica, California, United States
• Mayo Jacksonville / Brooks Rehabilitation — Jacksonville, Florida, United States
• Emory University Medical School — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• New York Presbyterian Hospital / Weill Cornell Medicine — New York, New York, United States
• Burke Medical Research Institute — White Plains, New York, United States
• Ohio State University - Neuroscience Research Institute — Columbus, Ohio, United States
• Thomas Jefferson — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Southwestern — Dallas, Texas, United States
• TIRR Memorial Hermann (UT Health Science Center at Houston) — Houston, Texas, United States
• Royal Aberdeen Infirmary — Aberdeen, United Kingdom
• University of Glasgow, Queen Elizabeth University Hospital — Glasgow, United Kingdom
• Royal London — London, United Kingdom
• Newcastle (Royal Victoria Infirmary) — Newcastle upon Tyne, United Kingdom
• Royal Hallamshire Hospital — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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