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Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

NCT03292159 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-09-21

No results posted yet for this study

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.

Conditions

  • Stroke
  • Upper Extremity Paresis

Interventions

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

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

Sponsors & Collaborators

  • Dana Foundation, Spaulding Rehabilitation Hospital

    collaborator UNKNOWN

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2018-11-20
Completion
2018-11-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292159 on ClinicalTrials.gov