Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke

Sponsor
Northwell Health (Other)
Overall Status
Completed
CT.gov ID
NCT03592745
Collaborator
(none)
36
1
2
33.7
1.1

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
  • Device: Transcutaneous Vagus Nerve Stimulation (tVNS)
  • Device: Sham Transcutaneous Vagus Nerve Stimulation (tVNS)
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

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a double-blind, sham controlled treatment study in which patients will have a 50/50 chance of receiving robotic arm therapy with either active transcutaneous vagus nerve stimulation (tVNS) or sham tVNS (placebo).This is a double-blind, sham controlled treatment study in which patients will have a 50/50 chance of receiving robotic arm therapy with either active transcutaneous vagus nerve stimulation (tVNS) or sham tVNS (placebo).
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Both the participants and investigators performing and analyzing clinical and objective outcome measures will remain blind to condition. Participants will be told that they have a 50-50 chance of receiving either active or sham stimulation, but they will not be told which condition they receive.
Primary Purpose:
Treatment
Official Title:
Evaluating the Use of Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Upper Limb Motor Recovery After Stroke
Actual Study Start Date :
Aug 9, 2018
Actual Primary Completion Date :
Jun 12, 2020
Actual Study Completion Date :
Jun 1, 2021

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:
  • Transauricular Vagus Nerve Stimulation
  • 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:
  • Sham Transauricular Vagus Nerve Stimulation
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Responsible Party:
    Bruce Volpe, Principal Investigator, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT03592745
    Other Study ID Numbers:
    • 18-0404
    First Posted:
    Jul 19, 2018
    Last Update Posted:
    Jun 29, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Bruce Volpe, Principal Investigator, Northwell Health
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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
    2. Secondary Outcome
    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

    [Not Specified]

    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
    Email jchang14@northwell.edu
    Responsible Party:
    Bruce Volpe, Principal Investigator, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT03592745
    Other Study ID Numbers:
    • 18-0404
    First Posted:
    Jul 19, 2018
    Last Update Posted:
    Jun 29, 2021
    Last Verified:
    May 1, 2021