Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a sham stimulation condition.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Promising new animal research suggests that vagus nerve stimulation paired with motor intervention induces movement-specific plasticity in the motor cortex and improves limb function after stroke. These results were recently extended to the first clinical trial, in which patients with stroke demonstrated significant improvements in upper limb function following rehabilitation paired with implanted VNS. Currently, vagus nerve stimulation is being used clinically to treat a number of human diseases including migraine headaches, epilepsy, and depression, and these investigations are expanding to deliver stimulation via a transcutaneous route to potentially improve intervention efficacy and decrease side effects. This pilot study will combine non-invasive transcutaneous stimulation of the vagus nerve with upper limb robotic therapy to investigate the potential of tVNS to augment improvements gained with robotic therapy in patients with chronic hemiparesis after stroke.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Device: 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.
Other Names:
|
Sham Comparator: 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. |
Device: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep [baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)]
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.
Secondary Outcome Measures
- Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score [baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Individuals between 18 and 85 years of age
-
First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
-
Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
-
Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).
Exclusion Criteria:
-
Botox treatment within 3 months of enrollment
-
Fixed contraction deformity in the affected limb
-
Complete and total flaccid paralysis of all shoulder and elbow motor performance
-
Prior injury to the vagus nerve
-
Severe dysphagia
-
Introduction of any new rehabilitation interventions during study
-
Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
-
Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
-
Pregnant or plan on becoming pregnant or breastfeeding during the study period
-
Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
-
Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Feinstein Institute for Medical Research | Manhasset | New York | United States | 11030 |
Sponsors and Collaborators
- Northwell Health
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
- Capone F, Miccinilli S, Pellegrino G, Zollo L, Simonetti D, Bressi F, Florio L, Ranieri F, Falato E, Di Santo A, Pepe A, Guglielmelli E, Sterzi S, Di Lazzaro V. Transcutaneous Vagus Nerve Stimulation Combined with Robotic Rehabilitation Improves Upper Limb Function after Stroke. Neural Plast. 2017;2017:7876507. doi: 10.1155/2017/7876507. Epub 2017 Dec 10.
- Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
- Hays SA. Enhancing Rehabilitative Therapies with Vagus Nerve Stimulation. Neurotherapeutics. 2016 Apr;13(2):382-94. doi: 10.1007/s13311-015-0417-z. Review.
- Khodaparast N, Hays SA, Sloan AM, Fayyaz T, Hulsey DR, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation delivered during motor rehabilitation improves recovery in a rat model of stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):698-706. doi: 10.1177/1545968314521006. Epub 2014 Feb 18.
- Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.
- Volpe BT, Huerta PT, Zipse JL, Rykman A, Edwards D, Dipietro L, Hogan N, Krebs HI. Robotic devices as therapeutic and diagnostic tools for stroke recovery. Arch Neurol. 2009 Sep;66(9):1086-90. doi: 10.1001/archneurol.2009.182. Review.
- 18-0404
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy |
---|---|---|
Arm/Group Description | 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 (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. |
Period Title: Overall Study | ||
STARTED | 18 | 18 |
COMPLETED | 15 | 15 |
NOT COMPLETED | 3 | 3 |
Baseline Characteristics
Arm/Group Title | Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy | Total |
---|---|---|---|
Arm/Group Description | 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 (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 of all reporting groups |
Overall Participants | 18 | 18 | 36 |
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
56.0
|
62.0
|
59.0
|
Sex: Female, Male (Count of Participants) | |||
Female |
9
50%
|
9
50%
|
18
50%
|
Male |
9
50%
|
9
50%
|
18
50%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
3
16.7%
|
1
5.6%
|
4
11.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
5
27.8%
|
4
22.2%
|
9
25%
|
White |
7
38.9%
|
10
55.6%
|
17
47.2%
|
More than one race |
2
11.1%
|
0
0%
|
2
5.6%
|
Unknown or Not Reported |
1
5.6%
|
3
16.7%
|
4
11.1%
|
Region of Enrollment (Count of Participants) | |||
United States |
18
100%
|
18
100%
|
36
100%
|
Outcome Measures
Title | Median Absolute Change From Baseline in Electromyographic (EMG) Peak Amplitude of the Bicep/Tricep |
---|---|
Description | 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. |
Time Frame | baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy |
---|---|---|
Arm/Group Description | 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 (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. |
Measure Participants | 15 | 14 |
Median absolute change in bicep peak amplitude from baseline to discharge after 3 weeks of training |
22.310
|
7.010
|
Median absolute change in tricep peak amplitude from baseline to discharge after 3 weeks of training |
16.070
|
10.055
|
Median absolute change in bicep peak amplitude from baseline to 3 month follow-up |
21.730
|
13.545
|
Median absolute change in tricep peak amplitude from baseline to 3 month follow-up |
10.520
|
11.455
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Active tVNS + Robotic Arm Therapy, Sham tVNS + Robotic Arm Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed). | |
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | The Mann-Whitney Wilcoxon test was performed to compare median absolute change in bicep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS). | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | U value |
Estimated Value | 32.000 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Active tVNS + Robotic Arm Therapy, Sham tVNS + Robotic Arm Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed). | |
Statistical Test of Hypothesis | p-Value | 0.445 |
Comments | The Mann-Whitney Wilcoxon test was performed to compare median absolute change in tricep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS). | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | U value |
Estimated Value | 87.000 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Active tVNS + Robotic Arm Therapy, Sham tVNS + Robotic Arm Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed). | |
Statistical Test of Hypothesis | p-Value | 0.678 |
Comments | The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in bicep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS). | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | U value |
Estimated Value | 95.000 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Active tVNS + Robotic Arm Therapy, Sham tVNS + Robotic Arm Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed). | |
Statistical Test of Hypothesis | p-Value | 0.777 |
Comments | The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in tricep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS). | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | U value |
Estimated Value | 98.000 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Median Change From Baseline in Upper Extremity Fugl Meyer Assessment Score |
---|---|
Description | 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. |
Time Frame | baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention) |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy |
---|---|---|
Arm/Group Description | 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 (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. |
Measure Participants | 15 | 15 |
Median change from baseline to discharge at 3 weeks |
2.000
|
2.500
|
Median change from baseline to 3 month follow-up |
2.330
|
1.670
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Active tVNS + Robotic Arm Therapy, Sham tVNS + Robotic Arm Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Statistical analysis of median change from baseline to DC immediately following 3 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed). | |
Statistical Test of Hypothesis | p-Value | 1.000 |
Comments | The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS). | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | U value |
Estimated Value | 112.000 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Active tVNS + Robotic Arm Therapy, Sham tVNS + Robotic Arm Therapy |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Statistical analysis of median change from baseline to week 16 (3 month follow-up) was assessed with the Upper Extremity Fugl Meyer score in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median change in Upper Extremity Fugl Meyer score between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed). | |
Statistical Test of Hypothesis | p-Value | 0.950 |
Comments | The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS). | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | U value |
Estimated Value | 110.500 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | 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. | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy | ||
Arm/Group Description | 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 (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. | ||
All Cause Mortality |
||||
Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/18 (0%) | 0/18 (0%) | ||
Serious Adverse Events |
||||
Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/18 (0%) | 0/18 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Active tVNS + Robotic Arm Therapy | Sham tVNS + Robotic Arm Therapy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/18 (0%) | 2/18 (11.1%) | ||
Infections and infestations | ||||
flu | 0/18 (0%) | 0 | 1/18 (5.6%) | 1 |
Injury, poisoning and procedural complications | ||||
wrist fracture | 0/18 (0%) | 0 | 1/18 (5.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Senior Research Coordinator |
---|---|
Organization | Feinstein Institutes for Medical Research at Northwell Health |
Phone | 5165623646 |
jchang14@northwell.edu |
- 18-0404