CompletedNot Applicable

Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

United States75 participantsStarted 2022-03-02

Plain-language summary

This study addresses the timely problem of painful temporomandibular disorders (TMD), the most common cause of orofacial pain second only to tooth pain. Findings from previous studies suggest that dysregulation of connectivity within specific brain circuits is part of chronic pain pathophysiology. This study will identify connectivity patterns within those brain circuits as potential signatures for pain- related disability in chronic TMD pain participants. New knowledge regarding these brain connectivity patterns is expected to be significant because it will support improved phenotyping of this heterogeneous participant population. It is also expected that this finding can potentially be extrapolated to other chronic pain conditions, such as back pain, migraine headache, and fibromyalgia that are frequently comorbid conditions in chronic TMD participants.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Main project * Provide signed and dated informed consent form. * Willing to comply with all study procedures and be available for the duration of study participation. * All participants will be females (biological sex by self-report) between ages 18 to 65 years (inclusive), as this includes the majority of the patient population at risk for chronic TMD pain. * Cases and controls will be matched for age within ±3 years, and all participants must be able to understand commands in English to follow study procedures (e.g., during sensory testing). Pain-free controls * TMD-Pain screener score less than 3 out of 7 (Screener available as part of the DC/TMD) * No previous diagnosis for the most common pain-related TMD as defined in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD) * No significant orofacial pain (jaw pain, TMJ pain) in past 3 months ("significant" meaning 5 or more days in any month or any pain during the past month) * No report of significant pain in the last 3 months elsewhere in the body ("significant" meaning 5 or more days in any month or any pain during the past month), e.g., low back pain, fibromyalgia, migraine headaches * Not meeting any of the most common pain-related TMD diagnosis as described in the DC/TMD criteria (myalgia, arthralgia, headache attributed to TMD) upon clinical examination following the DC/TMD protocol Chronic painful TMD cases * TMD-pain screener score equal to or greater than 3 * Primary TMD …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional connectivity (FC) for the thalamocortical brain circuit

Timeframe: 2.5 hours

Functional connectivity (FC) for the antinociceptive brain circuit

Timeframe: 2.5 hours

Functional connectivity (FC) for the corticolimbic brain circuit

Timeframe: 2.5 hours

Anatomical connectivity (AC) for the thalamocortical brain circuit

Timeframe: 2.5 hours

Anatomical connectivity (AC) for the antinociceptive brain circuit

Timeframe: 2.5 hours

Change in anatomical connectivity of corticolimbic brain circuit

Timeframe: 2.5 hours

Trial details

NCT IDNCT05068908

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-24

View on ClinicalTrials.gov More Chronic Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Functional connectivity (FC) for the thalamocortical brain circuit

Timeframe: 2.5 hours

Functional connectivity (FC) for the antinociceptive brain circuit

Timeframe: 2.5 hours

Functional connectivity (FC) for the corticolimbic brain circuit

Timeframe: 2.5 hours

Anatomical connectivity (AC) for the thalamocortical brain circuit

Timeframe: 2.5 hours

Anatomical connectivity (AC) for the antinociceptive brain circuit

Timeframe: 2.5 hours

Change in anatomical connectivity of corticolimbic brain circuit

Timeframe: 2.5 hours