Recruiting

tAN

Sponsor:

University of Minnesota

Code:

NCT07517172

Conditions

Temporomandibular Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Auricular Neurostimulation

Sham Stimulation

Study Details

Brief summary:

This study is a randomized, double-blind, sham-controlled feasibility trial designed to assess the acceptability and preliminary efficacy of Transcutaneous Auricular Neurostimulation (tAN) for individuals with Temporomandibular Disorders (TMD). Approximately 40 participants will be enrolled to evaluate whether daily, home-based tAN sessions-which deliver mild electrical pulses to the auricular branch of the vagus nerve-can effectively reduce chronic orofacial pain and improve associated cognitive and psychosocial dysfunctions. The study monitors feasibility through retention and adherence rates while tracking secondary outcomes such as pain intensity, cognitive flexibility, and mood changes using validated scales and wearable smartwatch data . Ultimately, this research aims to generate the critical data necessary to inform larger clinical trials and potentially offer a non-pharmacological, non-invasive treatment option for patients refractory to traditional TMD therapies.

Conditions

Temporomandibular Disorder

Study ID

NCT07517172

Start date

May 20, 2026

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 to 65 years.
  • Diagnosis of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).
  • Pain intensity of at least 4/10 on the Numeric Rating Scale (NRS) over the past two weeks.
  • Chronic pain duration of at least three months, consistent with diagnosis of chronic TMD.
  • Willingness to self-administer transcutaneous auricular nerve stimulation (tAN) at home and comply with study procedures.
  • Fluency in English to ensure comprehension of study materials and assessments.
  • Access to a smartphone or computer with internet to complete electronic study surveys and check-ins with the research team.

Exclusion Criteria:

  • Neurological conditions that may interfere with study outcomes, including epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
  • Use of implanted neuromodulation devices, such as vagus nerve stimulators, deep brain stimulators, or cochlear implants.
  • Unstable or severe psychiatric disorders, including active psychosis or severe depression with suicidal ideation.
  • Pregnancy or intention to become pregnant during the study period.
  • Skin conditions or other contraindications that prevent safe electrode placement on the auricular region (e.g., metal in the cymba concha that is unable or not willing to remove).
  • History of trauma (e.g., skull fracture) or periauricular surgery (e.g., temporomandibular joint replacement, acoustic neuroma removal) which would affect the location and function of the target peripheral innervation.
  • Use of both surgical and non-surgical bone conduction hearing devices.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active tAN

After the baseline assessments, participants will be trained to self-administer tAN at home according to their assigned condition (active or sham). They will be instructed to use the device daily for a minimum of two hours (maximum is 24 hours) while recording any side effects. The device's internal log will track session compliance, stimulation parameters, and usage frequency.

placebo comparator: Sham Stimulation

The sham condition will mimic active stimulation without delivering therapeutically active parameters, defined as electrical stimulation being provided to the earpiece electrode. The sham stimulation will be passive stimulation meaning that no electrical stimulation will be provided to the participant.

Interventions

Transcutaneous Auricular Neurostimulation

The intervention in this study is Transcutaneous Auricular Neurostimulation (tAN), a noninvasive neuromodulation technique that delivers mild electrical stimulation to the auricular branch of the vagus nerve (ABVN) via electrodes placed on the external ear.

Sham Stimulation

the sham condition will mimic active stimulation without delivering therapeutically active parameters, defined as electrical stimulation being provided to the earpiece electrode. The sham stimulation will be passive stimulation meaning that no electrical stimulation will be provided to the participant.

Primary outcome measure

  • Retention Rate [ Time Frame: Week 6 ]
  • Intervention Adherence [ Time Frame: Week 4 ]
  • Acceptability [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Carla Campbell

612-625-6976ohcrc@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Carla Campbell

612-625-6976ohcrc@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-29.