Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders

NCT05068908 | Recruiting

• 1 other identifier: DENT-2020-29282
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Temporomandibular Joint Disorders; Temporomandibular Joint Pain

Outcome Measures

Primary Outcomes (6)

• Functional connectivity (FC) for the thalamocortical brain circuit

  Multi-modal MRI data will be used to assess functional connectivity patterns within the thalamocortical brain circuit in chronic TMD pain participants and pain free controls. Functional connectivity will be reported as a unitless value. Neuroimaging will be conducted during Visit 3.

  2.5 hours

• Functional connectivity (FC) for the antinociceptive brain circuit

  Multi-modal MRI data will be used to assess functional connectivity patterns within the antinociceptive brain circuit in chronic TMD pain participants and pain free controls. Functional connectivity will be reported as a unitless value. Neuroimaging will be conducted during Visit 3.

  2.5 hours

• Functional connectivity (FC) for the corticolimbic brain circuit

  Multi-modal MRI data will be used to assess functional connectivity patterns within the corticolimbic brain circuit in chronic TMD pain participants and pain free controls. Functional connectivity will be reported as a unitless value. Neuroimaging will be conducted during Visit 3.

  2.5 hours

• Anatomical connectivity (AC) for the thalamocortical brain circuit

  Multi-modal MRI data will be used to assess anatomical connectivity patterns within the thalamocortical brain circuit in chronic TMD pain participants and pain free controls. Anatomical connectivity will be reported as a unitless value. Neuroimaging will be conducted during Visit 3.

  2.5 hours

• Anatomical connectivity (AC) for the antinociceptive brain circuit

  Multi-modal MRI data will be used to assess anatomical connectivity patterns within the antinociceptive brain circuit in chronic TMD pain participants and pain free controls. Anatomical connectivity will be reported as a unitless value. Neuroimaging will be conducted during Visit 3.

  2.5 hours

• Change in anatomical connectivity of corticolimbic brain circuit

  Multi-modal MRI data will be used to assess anatomical connectivity patterns within the corticolimbic brain circuit in chronic TMD pain participants and pain free controls. Anatomical connectivity will be reported as a unitless value. Neuroimaging will be conducted during Visit 3.

  2.5 hours

Secondary Outcomes (1)

• Temporal Summation of Pain (TSP) and Conditioned Pain Modulation (CPM) responses

  3.5 hours

Study Arms (4)

Low-impact chronic painful temporomandibular disorder (TMD) cases

Participants whose chronic painful TMD is determined to be low-impact. Visits include a standardized clinical examination using the Diagnostic Criteria for TMD (DC/TMD) protocol, psychosocial questionnaires completion, sensory and endogenous pain modulation (EPM) testing and a multi-modal Magnetic Resonance Imaging (MRI) data acquisition.

High- impact chronic painful temporomandibular disorder (TMD) cases

Participants whose chronic painful TMD is determined to be high-impact. Visits include a standardized clinical examination using the Diagnostic Criteria for TMD (DC/TMD) protocol, psychosocial questionnaires completion, sensory and endogenous pain modulation (EPM) testing and a multi-modal Magnetic Resonance Imaging (MRI) data acquisition.

Pain-free controls

Participants without chronic painful TMD. Visits include a standardized clinical examination using the Diagnostic Criteria for TMD (DC/TMD) protocol, psychosocial questionnaires completion, sensory and endogenous pain modulation (EPM) testing and a multi-modal Magnetic Resonance Imaging (MRI) data acquisition.

Pilot study-MRI optimization group

A pilot study will be conducted separately from the "main project" for optimization of MRI parameters, where up to five participants will be recruited as a separate group to undergo only MRI sessions (single study visit). The goal is to optimize the parameters of the main project's MR imaging protocol in order to minimize imaging distortions related to the presence of the thermodes in close proximity to the field of view for the brain.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Visits include a standardized clinical examination using the Diagnostic Criteria for TMD (DC/TMD) protocol, psychosocial questionnaires completion, quantitative sensory testing (QST) using a standard protocol, endogenous pain modulation (EPM) testing and a multi-modal Magnetic Resonance Imaging (MRI) data acquisition.

You may qualify if:

• 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 caseness criteria: myalgia (masticatory muscle pain) based on clinical exam following the DC/TMD protocol
• Concurrent arthralgia (TMJ pain) and/or headache attributed to TMD allowed
• Myofascial pain must meet the following criteria:

You may not qualify if:

• Traumatic facial injury or surgery on the face/jaw, arms or hands
• Presence of pain related to dental or periodontal pathology
• Currently undergoing active orthodontic treatment
• Pregnant or nursing
• Has any of the following medical conditions by self-report:
• Renal failure or dialysis
• Heart disease (examples: uncontrolled arrhythmia or hypertension, cardiomyopathy) or heart failure
• Non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema)
• Diabetes (Type I or II) that is not controlled with medication or diet
• Hyperthyroidism
• Uncontrolled seizures
• Used any injection therapy (i.e. tender or trigger point injections, steroid injections), acupuncture, biofeedback, or TENS for the management of facial pain within 2 weeks prior to the screening assessment
• If undergoing botulinum toxin injections in the head and neck areas, must be 3 months since last set of injections and refrain from this treatment until study has ended
• History of major depression or other major psychiatric disorder requiring hospitalization within the last 6 months prior to the screening assessments
• History of treatment for drug or alcohol abuse within the last 12 months

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Estephan J Moana-Filho, DDS, MS, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estephan J Moana-Filho, DDS, MS, PhD

CONTACT

(612) 624-3338; brainsensestudy@umn.edu

Lauren N Huffman

CONTACT

(612) 625-8926; brainsensestudy@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: March 2, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (1)