NCT06616831

Brief Summary

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
4mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Oct 2024Sep 2026

First Submitted

Initial submission to the registry

August 12, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

August 12, 2024

Last Update Submit

May 15, 2025

Conditions

StrokeStroke, IschemicStroke Hemorrhagic

Outcome Measures

Primary Outcomes (4)

  • Feasibility through dropout rates

    Dropout rates will be assessed over the course of the study.

    2 weeks

  • Safety of stimulation

    Any side effects or adverse events will be assessed.

    2 weeks

  • Compliance

    Compliance with study procedures will be assessed every study visit.

    2 weeks

  • Subjective ratings of feasibility.

    Feasibility will be assessed with subjective ratings on subject's ability to complete study procedures at home.

    2 weeks

Secondary Outcomes (2)

  • Compliance with at-home sessions

    2 weeks

  • Motor Function

    2 weeks

Study Arms (1)

Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training

EXPERIMENTAL

Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.

Device: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training

Interventions

Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific TrainingDEVICE

Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.

Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;
  • Ability to give consent;
  • Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;
  • active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;
  • Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

You may not qualify if:

  • Other concomitant neurological disorders affecting upper extremity motor function;
  • Presence of Dysphagia or aspiration difficulties;
  • Prior injury to vagus nerve;
  • Pregnancy;
  • Documented history of dementia before or after stroke;
  • Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
  • Uncontrolled hypertension;
  • Botox injections within 4 weeks of the first day of rehabilitation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

RECRUITING

Related Publications (1)

  • Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.

    PMID: 37209010BACKGROUND

MeSH Terms

Conditions

StrokeIschemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bashar Badran, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Tucker

CONTACT

843-792-9502tuckekat@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2024

First Posted

September 27, 2024

Study Start

October 28, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)