Health TrialsbyHealthPanel

At-Home taVNS - Stroke Rehab

ConditionsStrokeStroke, IschemicStroke Hemorrhagic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-80 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;

Disqualifiers

Other concomitant neurological disorders affecting upper extremity motor function;

Presence of Dysphagia or aspiration difficulties;

Prior injury to vagus nerve;

Pregnancy;

Trial design

Design model

Single group

Treatments tested in this trial

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

    Device

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

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility through dropout rates

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

Time frame
2 weeks
2

Safety of stimulation

Any side effects or adverse events will be assessed.

Time frame
2 weeks
3

Compliance

Compliance with study procedures will be assessed every study visit.

Time frame
2 weeks
4

Subjective ratings of feasibility.

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

Time frame
2 weeks

Secondary outcomes

1

Compliance with at-home sessions

The total number of completed at-home sessions will be measured. The total stimulation duration completed within each session. Benchmarks of \>80% total motor rehabilitation sessions completed, and 45 minute in-session duration will be the feasibility cutoffs for the analysis.

Time frame
2 weeks
2

Motor Function

Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA).

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov
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