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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of Transcutaneous Auricular Neurostimulation (tAN) as a noninvasive brain stimulation approach for reducing pain and improving cognitive function in individuals with Temporomandibular Disorders (TMD).
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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.
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.
  • Device: 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.

Recruiting Locations

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Carla Campbell
612-625-6976
ohcrc@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Carla Campbell
612-625-6976
ohcrc@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.