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Recruiting NCT07144436

Post-stroke Pain tAN-fMRI

No phase Interventional Post Stroke Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Auricular Neurostimulation.
Who it may be relevant to
Registry conditions: Post Stroke Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigating the Feasibility, Efficacy, and Renormalization of Pain-Regulation Brain Circuits Underlying At-Home Transcutaneous Auricular Neuromodulation (tAN) for Managing Chronic Post-Stroke Pain

Overview

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.

Detailed description

In this study, the investigators main goal is to establish transcutaneous auricular neurostimulation (tAN) as an effective non-invasive neuromodulation method for pain management of post-stroke pain (PSP) and to investigate the brain circuit changes between pre- and post-treatment in individuals with PSP using brain imaging techniques.

Aim 1. Assess the feasibility and efficacy of self-administered, at-home tAN for pain management in stroke survivors with chronic pain compared to sham.

Aim 2. Investigate pain-induced brain activity changes over a one-month tAN treatment to understand the analgesic mechanisms of tAN.

Aim 3. Explore renormalization of brain functional connectivity and dynamic brain state throughout tAN treatment and develop brain imaging biomarkers to track and predict treatment efficacy for chronic post-stroke pain.

Interventions

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

Primary outcome measures

  • Sensory Threshold [Time frame: 4 weeks]
  • Pain Threshold [Time frame: 4 weeks]
  • Pain tolerance [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Contraindicated for MRI scanning
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • 30 Bee Street — Charleston
  • Medical University of South Carolia — Charleston

Identifiers

NCT: NCT07144436 · Pro00145968

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗