Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

Phase 1

Terminated

• Conditions: Stroke; Upper Extremity Paresis
• Interventions: Device: Inactive RAVANS concurrent with arm motor training; Device: Active RAVANS concurrent with arm motor training

• Registration Number: NCT03292159
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-25
• Study Start: 2018-05-17
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Inactive RAVANS concurrent with arm motor training	-
RAVANS	Active RAVANS concurrent with arm motor training	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States