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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131960
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
ResearchPoint Global
Information provided by (Responsible Party):
MicroTransponder Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Stroke Upper Extremity Paresis Device: Paired Vagus Nerve Stimulation Other: Rehabilitation Not Applicable

Detailed Description:

This study has three distinct stages: Stage I, an acute blinded stage, Stage II, an unblinded stage through one year of standard VNS, and Stage III, an unblinded stage for yearly follow-up after one year of VNS. The Control group crosses over to VNS treatment at Stage II.

For Stage I, subjects have:

  • consent and evaluation (screening),
  • one pre-implant evaluation,
  • surgical implant of the device system and randomization into one of the treatment arms,
  • one baseline evaluation after device implant surgery but before initiation of treatment,
  • 6 weeks of treatment (standard-of-care rehabilitation + standard VNS or standard-of-care rehabilitation + active control VNS), and then
  • post-acute therapy evaluations at 1, 30 and 90 days after the 6 weeks of treatment.
  • Between Day 1 (V5) and Day 30 (V6) post-acute therapy, both groups will receive in-home, self-directed rehabilitation (30 minutes of daily rehabilitation as assigned by the therapist) with either in-home activated VNS (VNS group) or no VNS (Control group). This means that the control subjects will not have the in-home activated VNS until they complete the second 6-week session of in-clinic rehabilitation with follow-up assessments as described below in Stage II. At this point (Day 30) subjects start scheduling for their continuing long-term follow-up.
  • Between Day 30 and Day 90 post-acute therapy, both groups continue in-home, self-directed rehabilitation (30 minutes of daily rehabilitation as assigned by the therapist). The VNS group continues to receive in-home VNS with magnet use; the Control group continues to use the magnet but does not receive any VNS. The Day 90 post-acute therapy visit is V7; it is the first quarterly visit (3 months after study therapy) for the VNS group and is the re-baseline visit (visit just prior to the initiation of standard VNS therapy) for the Control group.

Stage II:

  • VNS subjects will continue to have quarterly assessments through the end of the first year (6m, 9m, 12m).
  • Subjects in the control group will crossover for a second 6-week in-clinic rehabilitation period where they will now receive rehabilitation with standard VNS.
  • Control subjects will then have the three post therapy assessments (1, 30 and 90 days after therapy ends); in-home VNS initiated by a magnet swipe starts at the Post-1 visit (LT1). Thereafter, control subjects will follow the same schedule as VNS subjects for the remainder of the study (6m, 9m, 12m follow-ups, plus yearly visits thereafter).
  • Subjects in both groups will receive "booster" in-clinic rehabilitation plus VNS therapy sessions one month prior to their 6- and 12-month assessment visits. These sessions occur on three days over a one-week period (typically Mon, Wed, Fri).

Stage III:

• After one year of standard VNS therapy (~13.5 months after implant for VNS group subjects and ~18 months after implant for Control group subjects), subjects who wish to keep their device for further use will have annual follow-up assessments until commercial approval.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, randomized, parallel study with partial crossover (control subjects crossover to treatment after randomized portion)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, therapists (care providers), investigators, and outcomes assessors do not know which group (VNS or control VNS) the patients are randomized. Only one person at the site - the programmer who programs the device settings - knows which group the subject is randomized into.
Primary Purpose: Treatment
Official Title: A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: VNS + Rehabilitation (1)
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Device: Paired Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.

Other: Rehabilitation
Rehabilitation movements to improve upper limb function after stroke

Active Comparator: Control VNS
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.
Other: Rehabilitation
Rehabilitation movements to improve upper limb function after stroke




Primary Outcome Measures :
  1. Fugl-Meyer Assessment, Upper Limb (FM-A) [ Time Frame: V5, One day after 6-weeks of therapy ]
    FM-A 1-day


Secondary Outcome Measures :
  1. Fugl-Meyer Assessment, Upper Limb (FM-A) [ Time Frame: V7, 90 days after 6-weeks of therapy ]
    FM-A 90-day

  2. Fugl-Meyer Assessment, Upper Limb (FM-A) Response [ Time Frame: V7, 90 days after 6-weeks of therapy ]
    FM-A Response

  3. Wolf Motor Function Test [ Time Frame: V7, 90 days after 6-weeks of therapy ]
    WMFT 90-day



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of hemorrhagic stroke
  2. Presence of ongoing dysphagia or aspiration difficulties.
  3. 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.
  4. Prior injury to vagus nerve, either bilateral or unilateral (e.g., injury during carotid endarterectomy).
  5. Severe or worse depression (Beck Depression Scale > 29) (Beck et al., 1961)
  6. Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
  7. Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug.
  8. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.
  9. Pregnancy or plans to become pregnant or to breastfeed during the study period.
  10. Current requirement, or likely future requirement, of diathermy during the study duration.
  11. Active rehabilitation within 4 weeks prior to consent.
  12. 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).
  13. Severe spasticity of the upper limb (Modified Ashworth ≥3) (Bohannon and Smith, 1987).
  14. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131960


Locations
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United States, Arizona
Perseverance Research Center
Scottsdale, Arizona, United States, 85254
United States, California
Rancho Research Institute
Downey, California, United States, 90242
Providence St. John's Medical Center
Santa Monica, California, United States, 90404
United States, Florida
Mayo Jacksonville / Brooks Rehabilitation
Jacksonville, Florida, United States, 32224
United States, Georgia
Emory University Medical School
Atlanta, Georgia, United States, 30329
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, New York
New York Presbyterian Hospital / Weill Cornell Medicine
New York, New York, United States, 10065
Burke Medical Research Institute
White Plains, New York, United States, 10605
United States, Ohio
Ohio State University - Neuroscience Research Institute
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37240
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
TIRR Memorial Hermann (UT Health Science Center at Houston)
Houston, Texas, United States, 77030
United Kingdom
Royal Aberdeen Infirmary
Aberdeen, United Kingdom, AB25 2ZB
University of Glasgow, Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Royal London
London, United Kingdom, E15 4LZ
Newcastle (Royal Victoria Infirmary)
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Royal Hallamshire Hospital
Sheffield, United Kingdom, S1 4DA
Sponsors and Collaborators
MicroTransponder Inc.
ResearchPoint Global

Publications:
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Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT03131960     History of Changes
Other Study ID Numbers: MT-St-03
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms