Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB) (VNS-REHAB)
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ClinicalTrials.gov Identifier: NCT03131960 |
Recruitment Status :
Active, not recruiting
First Posted : April 27, 2017
Results First Posted : June 14, 2021
Last Update Posted : March 31, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Cerebrovascular Stroke Upper Extremity Paresis |
Interventions |
Device: Paired Vagus Nerve Stimulation Other: Rehabilitation |
Enrollment | 108 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | VNS + Rehabilitation (1) | Control VNS |
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Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements. Rehabilitation: Rehabilitation movements to improve upper limb function after stroke |
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. Rehabilitation: Rehabilitation movements to improve upper limb function after stroke |
Period Title: Overall Study | ||
Started | 53 [1] | 55 [2] |
Completed | 53 | 54 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
Adverse Event | 0 | 1 |
[1]
1 participant missed the day one visit (V5) but remained in the study and returned for the day 90 assessment (V7).
[2]
1 discontinued treatment due to adverse event and inability to tolerate rehabilitation.
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Arm/Group Title | VNS + Rehabilitation (1) | Control VNS | Total | |
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Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements. Rehabilitation: Rehabilitation movements to improve upper limb function after stroke |
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. Rehabilitation: Rehabilitation movements to improve upper limb function after stroke |
Total of all reporting groups | |
Overall Number of Baseline Participants | 53 | 55 | 108 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 53 participants | 55 participants | 108 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
30 56.6%
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35 63.6%
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65 60.2%
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>=65 years |
23 43.4%
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20 36.4%
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43 39.8%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 53 participants | 55 participants | 108 participants | |
59.1 (10.2) | 61.1 (9.2) | 60.1 (9.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 53 participants | 55 participants | 108 participants | |
Female |
19 35.8%
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19 34.5%
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38 35.2%
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Male |
34 64.2%
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36 65.5%
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70 64.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 53 participants | 55 participants | 108 participants | |
American Indian or Alaska Native |
0 0.0%
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1 1.8%
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1 0.9%
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Asian |
1 1.9%
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2 3.6%
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3 2.8%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
9 17.0%
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9 16.4%
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18 16.7%
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White |
42 79.2%
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42 76.4%
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84 77.8%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
1 1.9%
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1 1.8%
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2 1.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 53 participants | 55 participants | 108 participants |
United States | 36 | 38 | 74 | |
United Kingdom | 17 | 17 | 34 | |
FMA-UE Baseline Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 53 participants | 55 participants | 108 participants | |
34.4 (8.2) | 35.7 (7.8) | 35.1 (8.0) | ||
[1]
Measure Description: The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). The study allowed entry on the FMA-UE between 20 and 50.
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WMFT Baseline Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 53 participants | 55 participants | 108 participants | |
2.71 (0.70) | 2.83 (0.65) | 2.76 (0.67) | ||
[1]
Measure Description: The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal).
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Name/Title: | Study Director |
Organization: | MicroTransponder Inc. |
Phone: | 8556289375 |
EMail: | studies@microtransponder.com |
Responsible Party: | MicroTransponder Inc. |
ClinicalTrials.gov Identifier: | NCT03131960 |
Other Study ID Numbers: |
MT-St-03 |
First Submitted: | April 24, 2017 |
First Posted: | April 27, 2017 |
Results First Submitted: | April 27, 2021 |
Results First Posted: | June 14, 2021 |
Last Update Posted: | March 31, 2022 |