Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

NCT ID: NCT03292159

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-17
• Study Completion Date: 2018-11-20

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.

Conditions

Stroke; Upper Extremity Paresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RAVANS

Group Type: EXPERIMENTAL

Active RAVANS concurrent with arm motor training

Intervention Type: DEVICE

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 stimulation

Group Type: SHAM_COMPARATOR

Inactive RAVANS concurrent with arm motor training

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana Foundation, Spaulding Rehabilitation Hospital

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Judith Schaechter

Assistant Professor, Department of Radiology, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2017P000129

Identifier Type: -

Identifier Source: org_study_id