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The study aims to examine the effects of transcutaneous non-invasive vagus nerve stimulation (nVNS) on symptoms and brain mechanisms in premenopausal women with temporomandibular disorders (TMD). Non-invasive vagus nerve stimulation (nVNS) is the most well researched and possibly the most effective non-invasive neuromodulation treatment for chronic pain conditions that targets the brain-gut-microbiome (BGM) axis.
Participants will be asked to come in for 2 in-clinic visits, at baseline and post treatment. Participants will also be asked to come in 2x/week for 8 consecutive weeks to receive the nVNS treatment. The in-clinic visits will include physical measures, blood draw, saliva sample, and brain MRI. Participants will be asked to collect a stool sample at home and answer online questionnaires regarding, mood, pain, and health behaviors at home, prior to the in-clinic appointments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active nVNS Treatment | Experimental | nVNS Treatment 2x/week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nVNS Treatment | Device | nVNS treatment 2x/week for 8 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | To be measured using a numeric rating scale 0-10. | From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session. |
| Pain Unpleasantness | To be measured using a visual analog scale. | From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session. |
| Positive and Negative Affect | To be measured using the positive and negative affect scale (PANAS). | From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session. |
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Inclusion Criteria:
Ages 18-50
Premenopausal menstruating women*
Participants report or present with at least 1 of 3 cardinal signs of TMD: jaw pain, limited mouth opening, or TMJ noise.
Specific screening reveals clinical findings that require standard of care medically-indicated intra-articular procedure for management of symptoms including TMJ pain, intra-articular joint disorder leading to joint locking or limited mouth opening or displacement, and severe degenerative joint disease.
Must have a negative urine test for pregnancy
Ability to speak the English language fluently due to the standardized assessments involved
Right-handed (participants are limited to right-handed individuals to reduce variability in brain lateralization and ensure more consistent, interpretable data).
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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Pilot/Feasibility, Pre/Post Intervention Study
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |