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

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ClinicalTrials.gov Identifier: NCT03592745
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

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
Stroke Cerebrovascular Accident (CVA) Hemiparesis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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).
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 : August 9, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

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 Name: 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 Name: Sham Transauricular Vagus Nerve Stimulation




Primary Outcome Measures :
  1. Mean change in electromyographic (EMG) activation patterns of the bicep/tricep [ Time Frame: baseline, discharge at 3 weeks (immediately following the intervention), and follow-up at 16 weeks (3 months after the intervention) ]
    The mean change in electromyographic (EMG) activation patterns of the bicep/tricep during gravity-eliminated, unassisted elbow extensor movements 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)


Secondary Outcome Measures :
  1. Median Change in Upper Extremity Fugl Meyer Assessment Score [ Time Frame: 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 total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592745


Contacts
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Contact: Johanna Chang, MS 516-562-3646 jchang14@northwell.edu
Contact: Bruce T Volpe, MD 516-562-3384 bvolpe1@northwell.edu

Locations
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United States, New York
Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact: Johanna Chang, MS    516-562-3646    jchang14@northwell.edu   
Contact: Bruce T Volpe, MD    516-562-3384    bvolpe1@northwell.edu   
Sub-Investigator: Maira Saul, MD         
Sub-Investigator: Alexandra Paget-Blanc, BS         
Sponsors and Collaborators
Northwell Health

Publications:

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Responsible Party: Bruce Volpe, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT03592745    
Other Study ID Numbers: 18-0404
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Bruce Volpe, Northwell Health:
Transcutaneous vagus nerve stimulation (tVNS)
VNS
robotic therapy
occupational therapy
motor rehabilitation
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms