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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tAN | Active Comparator | 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. |
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| Sham Stimulation | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Neurostimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | The proportion of enrolled participants who complete both baseline and post-treatment assessments. A retention rate of ≥50% is considered feasible. | Week 6 |
| Intervention Adherence | The percentage of prescribed tAN sessions completed by each participant, as recorded in the internal device log. Feasibility is defined as ≥50% adherence to scheduled sessions. | Week 4 |
| Acceptability | Measured using a post-treatment Likert scale survey, where participants will rate comfort, usability, and willingness to use tAN again on a 1 to 5 scale. A mean acceptability score of ≥3/5 indicates feasibility. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carla Campbell | Contact | 612-625-6976 | ohcrc@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Donald Nixdorf, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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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).
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| Sham Stimulation | Device | 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. |
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |