Recruiting

tAN

Sponsor:

Medical University of South Carolina

Code:

NCT07144436

Conditions

Post Stroke Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Auricular Neurostimulation

Study Details

Brief summary:

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.

Conditions

Post Stroke Pain

Study ID

NCT07144436

Start date

Jan 8, 2026

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 2 Weeks Sham tAN followed by 2 Weeks Active tAN

Participants will be randomized to receive 2 weeks of at-home, self-administered sham Transcutaneous Auricular Neurostimulation (tAN), followed by 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).

experimental: Four Weeks of Active Transcutaneous Auricular Neurostimulation

Participants will be randomized to receive 2 weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN), followed by 2 additional weeks of at-home, self-administered active Transcutaneous Auricular Neurostimulation (tAN).

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Institutional RBFHR Recruitment Contact

843-792-9502suttonf@musc.edu

Locations

30 Bee Street

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Falon Sutton

8437929502suttonf@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Pain
  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-02-04.