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 2, 2020
|
Sponsor:
MicroTransponder Inc.
Collaborator:
ResearchPoint Global
Information provided by (Responsible Party):
MicroTransponder Inc.
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | April 24, 2017 | ||||||
First Posted Date ICMJE | April 27, 2017 | ||||||
Last Update Posted Date | September 2, 2020 | ||||||
Actual Study Start Date ICMJE | July 1, 2017 | ||||||
Actual Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Fugl-Meyer Assessment, Upper Limb (FM-A) [ Time Frame: V5, One day after 6-weeks of therapy ] FM-A 1-day
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB) | ||||||
Official Title ICMJE | A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB) | ||||||
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. | ||||||
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:
Stage II:
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. |
||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | 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
|
||||||
Condition ICMJE |
|
||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * |
|
||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
108 | ||||||
Original Estimated Enrollment ICMJE |
120 | ||||||
Estimated Study Completion Date ICMJE | June 30, 2021 | ||||||
Actual Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 22 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03131960 | ||||||
Other Study ID Numbers ICMJE | MT-St-03 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Responsible Party | MicroTransponder Inc. | ||||||
Study Sponsor ICMJE | MicroTransponder Inc. | ||||||
Collaborators ICMJE | ResearchPoint Global | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | MicroTransponder Inc. | ||||||
Verification Date | August 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |