Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03292159

Collaborator

Dana Foundation, Spaulding Rehabilitation Hospital (Other)

Enrollment

Location

Arms

6.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.

Condition or Disease	Intervention/Treatment	Phase
Stroke Upper Extremity Paresis	Device: Active RAVANS concurrent with arm motor training Device: Inactive RAVANS concurrent with arm motor training	Phase 1/Phase 2

Detailed Description

This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Safety and Effectiveness of Transcutaneous Vagus Nerve Stimulation Therapy to Improve Motor Recovery After Stroke

Actual Study Start Date :

May 17, 2018

Actual Primary Completion Date :

Nov 20, 2018

Actual Study Completion Date :

Nov 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RAVANS	Device: Active RAVANS concurrent with arm motor training Patient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training
Sham Comparator: Sham stimulation	Device: Inactive RAVANS concurrent with arm motor training Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training

Arm

Intervention/Treatment

Experimental: RAVANS

Device: Active RAVANS concurrent with arm motor training

Patient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training

Sham Comparator: Sham stimulation

Device: Inactive RAVANS concurrent with arm motor training

Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training

Outcome Measures

Primary Outcome Measures

Upper extremity motor impairment [Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke]
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score

Secondary Outcome Measures

Upper extremity motor function [Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke]
Change in Action Research Arm Test (ARAT) score
Grip force control [Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke]
Change in accuracy, variability and temporal structure of performance on a grip force control task
Upper extremity disability [Baseline to 3 months post-stroke]
Change in hand subtest of Stroke Impact Scale (SIS-hand) score
Mood state, anxiety and depression [Baseline to 3 months post-stroke]
Change in Hospital Anxiety and Depression Scale (HADS) scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior;
Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4);
Age ≥ 18;
Able to provide written informed consent.

Exclusion Criteria:

Implanted electronic device (e.g., pacemaker, neurostimulator);
Pregnancy;
Major psychiatric or medical condition that could interfere with study participation;
Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia);
Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by Stroke Impact Scale item 7 (SIS-hand) mean score < 4 (scale: 0-5);
History of seizure during year before stroke or > 1 post-stroke seizure;
Significant cognitive or language impairment that would interfere with informed consent or study participation;
Severe dysphagia;
Bradycardia defined as resting heart rate < 50 bpm;
Nonsustained ventricular tachycardia;
Cardiac conduction disorder (i.e., bundle branch block, heart block, long Q-T syndrome);
History of asystole;
History of recurrent vaso-vagal syncope;
Hypotension defined as blood pressure < 90/60 mmHg.