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Behavioural Intervention

Ear Stimulation for Post-Stroke Pain

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80
Have the capacity and ability to provide one's own consent in English and sign the informed consent document
Must not have
Documented history of uncontrolled depression or psychiatric disorder
Primary intracerebral hematoma or subarachnoid hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline subjective pain rating immediately post-tavns

Summary

"This trial will investigate if using a non-invasive ear stimulation technique called transcutaneous auricular vagus nerve stimulation (taVNS) can help reduce chronic post-stroke upper extremity pain in

Who is the study for?
This trial is for up to 20 people who have chronic pain in their arm after a stroke. Participants should be experiencing this specific type of post-stroke pain to qualify.
What is being tested?
The study is testing if transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive ear stimulation, can help reduce the perception of pain in participants with post-stroke arm pain.
What are the potential side effects?
Possible side effects may include discomfort at the site of stimulation, headache, or dizziness. However, as taVNS is non-invasive, severe side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I can understand and sign the consent form in English by myself.
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I had a stroke that affected the left side of my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of untreated or uncontrolled mental health issues.
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I have had a stroke caused by bleeding in the brain.
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My blood pressure is not controlled, even with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline pain threshold immediately post-tavns
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline pain threshold immediately post-tavns for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Thermal Pain Threshold
Secondary study objectives
Subjective Pain Ratings

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Auricular Neurostimulation (Active)Active Control1 Intervention
Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.
Group II: Auricular Neurostimulation (Sham)Placebo Group1 Intervention
Participants will receive auricular stimulation of 15Hz on their earlobe.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
967 Previous Clinical Trials
7,399,676 Total Patients Enrolled
71 Trials studying Stroke
62,076 Patients Enrolled for Stroke
~13 spots leftby Jun 2025
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