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Post-stroke Pain tAN-fMRI

ConditionPost Stroke Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical University of South Carolina

About this trial

The purpose of this study is to explore whether 4 weeks of at-home transcutaneous auricular neurostimulation (tAN) can reduce chronic pain after a stroke. Investigators will recruit up to 24 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80

Have the capacity and ability to provide one's own consent in English and sign the informed consent document.

Ischemic or hemorrhagic stroke that occurred at least 6 months prior

Disqualifiers

Primary intracerebral hematoma or subarachnoid hemorrhage

Documented history of dementia

Documented history of uncontrolled depression or psychiatric disorder

Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) >=180/100mmHg

Trial design

Design model

Crossover

Treatments tested in this trial

  • Transcutaneous Auricular Neurostimulation

    Device

    Transcutaneous Auricular Neurostimulation (tAN) is a wearable, electrical stimulation device that delivers electricity to specific parts of the human ear.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: 2 Weeks Sham tAN followed by 2 Weeks Active tANExperimental treatment 1 intervention
Group B: Four Weeks of Active Transcutaneous Auricular NeurostimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sensory Threshold

We will determine the pain threshold with a 30 × 30 mm thermode attached to the non-affected forearm of participants (TSA2 thermode; Medoc, Durham, NC, USA). Using the TSA2, we will determine heat sensitivity beginning at 32°C and increasing by 0.5°C per second. Participants will be asked to press a button (to record temperatures) when the stimulus is first detected (sensory threshold). We will acquire QST data at baseline, after one session (30 minutes) of tAN, after 2 weeks of tAN, and after 4 weeks of tAN.

Time frame
4 weeks
2

Pain Threshold

We will determine the pain threshold with a 30 × 30 mm thermode attached to the non-affected forearm of participants (TSA2 thermode; Medoc, Durham, NC, USA). Using the TSA2, we will determine heat sensitivity beginning at 32°C and increasing by 0.5°C per second. Participants will be asked to press a button (to record temperatures) when the stimulus becomes painful (pain threshold). We will acquire QST data at baseline, after one session (30 minutes) of tAN, after 2 weeks of tAN, and after 4 weeks of tAN.

Time frame
4 weeks
3

Pain tolerance

We will determine the pain threshold with a 30 × 30 mm thermode attached to the non-affected forearm of participants (TSA2 thermode; Medoc, Durham, NC, USA). Using the TSA2, we will determine heat sensitivity beginning at 32°C and increasing by 0.5°C per second. Participants will be asked to press a button (to record temperatures) when the stimulus is intolerable (pain tolerance). We will acquire QST data at baseline, after one session (30 minutes) of tAN, after 2 weeks of tAN, and after 4 weeks of tAN.

Time frame
4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov
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