Trial Outcomes & Findings for Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke (NCT NCT03592745)
NCT ID: NCT03592745
Last Updated: 2021-06-29
Results Overview
The median absolute change in surface electromyographic (sEMG) peak amplitude of the bicep/tricep during gravity-eliminated, unassisted extensor movements was calculated from baseline to discharge at 3 weeks (immediately following the intervention) and again at 16 weeks (3 months follow-up from the intervention) in each training condition (sham tVNS + robotic arm training vs. active tVNS + robotic arm training). Bicep and tricep peak sEMG amplitude scores were calculated as a percentage of the maximal volitional contraction (MVC), with larger values indicating a greater absolute change (negative or positive) in bicep/tricep peak muscle activity during extensor movements.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)
Results posted on
2021-06-29
Participant Flow
Participant milestones
| Measure |
Active tVNS + Robotic Arm Therapy
Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
|
Sham tVNS + Robotic Arm Therapy
Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Active tVNS + Robotic Arm Therapy
Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
|
Sham tVNS + Robotic Arm Therapy
Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
study temporary closure due to covid-19 pandemic
|
1
|
1
|
Baseline Characteristics
Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke
Baseline characteristics by cohort
| Measure |
Active tVNS + Robotic Arm Therapy
n=18 Participants
Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
|
Sham tVNS + Robotic Arm Therapy
n=18 Participants
Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
n=5 Participants
|
62.0 years
n=7 Participants
|
59.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)Population: 30 patients completed 9 sessions (3x/week for 3 weeks) of robotic arm training + sham or active tVNS, and 3 month follow-up at 16 weeks. One patient in the sham condition had corrupted sEMG measures, so 29 participants were consequently included in the efficacy analysis.
The median absolute change in surface electromyographic (sEMG) peak amplitude of the bicep/tricep during gravity-eliminated, unassisted extensor movements was calculated from baseline to discharge at 3 weeks (immediately following the intervention) and again at 16 weeks (3 months follow-up from the intervention) in each training condition (sham tVNS + robotic arm training vs. active tVNS + robotic arm training). Bicep and tricep peak sEMG amplitude scores were calculated as a percentage of the maximal volitional contraction (MVC), with larger values indicating a greater absolute change (negative or positive) in bicep/tricep peak muscle activity during extensor movements.
Outcome measures
| Measure |
Active tVNS + Robotic Arm Therapy
n=15 Participants
Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
|
Sham tVNS + Robotic Arm Therapy
n=14 Participants
Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
|
|---|---|---|
|
Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep
Median absolute change in tricep peak amplitude from baseline to discharge after 3 weeks of training
|
16.070 percentage of MVC
Interval 11.46 to 19.93
|
10.055 percentage of MVC
Interval 5.33 to 32.553
|
|
Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep
Median absolute change in bicep peak amplitude from baseline to discharge after 3 weeks of training
|
22.310 percentage of MVC
Interval 16.78 to 32.63
|
7.010 percentage of MVC
Interval 2.057 to 13.845
|
|
Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep
Median absolute change in bicep peak amplitude from baseline to 3 month follow-up
|
21.730 percentage of MVC
Interval 3.24 to 33.85
|
13.545 percentage of MVC
Interval 3.01 to 29.618
|
|
Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep
Median absolute change in tricep peak amplitude from baseline to 3 month follow-up
|
10.520 percentage of MVC
Interval 6.42 to 24.07
|
11.455 percentage of MVC
Interval 7.303 to 18.848
|
SECONDARY outcome
Timeframe: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)Population: 30 patients completed 9 sessions (3x/week for 3 weeks) of robotic arm training + sham or active tVNS, and 3 month follow-up at 16 weeks. A total of 30 participants were consequently included in the efficacy analysis.
The median change in Upper Extremity Fugl-Meyer Score will be calculated from baseline to discharge at 3 weeks (immediately following the intervention) and again at 16 weeks (3 months follow-up from the intervention) in each training condition (sham tVNS + robotic arm training vs. active tVNS + robotic arm training). The median change in Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
Outcome measures
| Measure |
Active tVNS + Robotic Arm Therapy
n=15 Participants
Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
|
Sham tVNS + Robotic Arm Therapy
n=15 Participants
Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
|
|---|---|---|
|
Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score
Median change from baseline to discharge at 3 weeks
|
2.000 scores on a scale
Interval 1.5 to 5.5
|
2.500 scores on a scale
Interval 1.5 to 4.5
|
|
Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score
Median change from baseline to 3 month follow-up
|
2.330 scores on a scale
Interval 0.05 to 5.5
|
1.670 scores on a scale
Interval 1.0 to 4.5
|
Adverse Events
Active tVNS + Robotic Arm Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tVNS + Robotic Arm Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tVNS + Robotic Arm Therapy
n=18 participants at risk
Transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
|
Sham tVNS + Robotic Arm Therapy
n=18 participants at risk
Sham (placebo) transcutaneous Vagus Nerve Stimulation (tVNS) will be delivered non-invasively via the ear (targeting the auricular branch of the vagus nerve) during robotic arm therapy sessions lasting \~60 minutes, 3x per week for 3 weeks.
Sham Transcutaneous Vagus Nerve Stimulation (tVNS): tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
|
|---|---|---|
|
Infections and infestations
flu
|
0.00%
0/18 • Adverse event data were collected for approximately 4 months, including the 3 week duration of the study intervention and the subsequent 3 month follow-up period.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for approximately 4 months, including the 3 week duration of the study intervention and the subsequent 3 month follow-up period.
|
|
Injury, poisoning and procedural complications
wrist fracture
|
0.00%
0/18 • Adverse event data were collected for approximately 4 months, including the 3 week duration of the study intervention and the subsequent 3 month follow-up period.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected for approximately 4 months, including the 3 week duration of the study intervention and the subsequent 3 month follow-up period.
|
Additional Information
Senior Research Coordinator
Feinstein Institutes for Medical Research at Northwell Health
Phone: 5165623646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place