Trial Outcomes & Findings for VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke (NCT NCT02243020)
NCT ID: NCT02243020
Last Updated: 2022-09-15
Results Overview
Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
6-weeks
Results posted on
2022-09-15
Participant Flow
Recruitment was from January 2016 through August 2017 at 3 US and 1 UK sites.
Participant milestones
| Measure |
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stimulation (VNS)
|
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Vagus Nerve Stimulation (VNS)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke
Baseline characteristics by cohort
| Measure |
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
n=8 Participants
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stimulation (VNS)
|
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
n=9 Participants
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Vagus Nerve Stimulation (VNS)
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 7.4 • n=39 Participants
|
60.0 years
STANDARD_DEVIATION 13.5 • n=41 Participants
|
59.8 years
STANDARD_DEVIATION 10.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Time Since Stroke
|
1.5 years
STANDARD_DEVIATION .7 • n=39 Participants
|
1.5 years
STANDARD_DEVIATION .3 • n=41 Participants
|
1.5 years
STANDARD_DEVIATION .5 • n=35 Participants
|
|
Baseline Upper Extremity Fugl-Meyer (UEFM)
|
29.5 units on a scale
STANDARD_DEVIATION 6.4 • n=39 Participants
|
36.4 units on a scale
STANDARD_DEVIATION 9.4 • n=41 Participants
|
33.2 units on a scale
STANDARD_DEVIATION 8.0 • n=35 Participants
|
PRIMARY outcome
Timeframe: 6-weeksMeasurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
n=8 Participants
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stimulation (VNS)
|
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
n=9 Participants
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Vagus Nerve Stimulation (VNS)
|
|---|---|---|
|
Change in Upper Extremity Fugl-Meyer (UEFM)
|
7.6 units on a scale
Standard Deviation 4.8
|
5.3 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6-weeksMeasurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.
Outcome measures
| Measure |
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
n=8 Participants
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stimulation (VNS)
|
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
n=9 Participants
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Vagus Nerve Stimulation (VNS)
|
|---|---|---|
|
Change in Wolf Motor Function Test Functional Assessment (WMFT)
|
0.25 units on a scale
Standard Deviation 0.24
|
.13 units on a scale
Standard Deviation .17
|
Adverse Events
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
n=8 participants at risk
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stimulation (VNS)
|
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
n=9 participants at risk
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Vagus Nerve Stimulation (VNS)
|
|---|---|---|
|
Infections and infestations
Wound Infection
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath and Dysphagia
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)
n=8 participants at risk
This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stimulation (VNS)
|
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator
n=9 participants at risk
This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
Vagus Nerve Stimulation (VNS)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain/Bruising from implant surgery
|
50.0%
4/8 • Number of events 4
|
44.4%
4/9 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place