N/A
N=108
Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
Cerebrovascular Stroke · Upper Extremity Paresis
Bottom Line
View on ClinicalTrials.gov: NCT03131960 ↗Enrolled (actual)
108
Serious AEs
7.4%
Results posted
Jun 2021
Primary outcome: Primary: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change — 5.0; 2.4 units on a scale — p=0.0014
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Paired Vagus Nerve Stimulation (Device); Rehabilitation (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- MicroTransponder Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change |
5.8; 2.8 | 0.0077 sig |
| SECONDARY Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change |
5.8; 2.8 | 0.0077 sig |
| SECONDARY Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response |
25; 13 | 0.0098 sig |
| SECONDARY Wolf Motor Function Test (WMFT) Average Change |
0.46; 0.16 | <0.0001 sig |
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) and baseline FMA UE (20 to 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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT03131960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.