FMRI Study on DC/TMD Patients

NCT07259902 | Not Yet Recruiting

• 1 other identifier: DC/TMD01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Temporomandibular disorders (TMD) are among the most common causes of chronic pain worldwide. It is estimated that about 5-12% of the global population is affected, and some conditions, such as arthritis, may be causative factors. Depending on severity, the joints involved can affect multiple functions of the masticatory system, such as the ability to speak, chew, swallow, limit facial expressions, and even breathe. Moreover, most patients with TMD may report painful conditions in other parts of the body, with comorbidities including chronic fatigue syndrome, chronic headache, endometriosis, fibromyalgia, interstitial cystitis, irritable bowel syndrome, back pain, sleep disorders, and vulvodynia. Another significant condition that frequently occurs alongside TMD is psychological distress in the form of anxiety and/or depression. The study proposed by this research protocol aims to investigate the presence of TMD and associated psychological/psychiatric disorders such as anxiety and depression. The innovative value of the research lies in evaluating whether the association between these disorders may lead to neuroplastic changes at the brain level, which could guide targeted therapies. Only a few studies in the literature have explored this possible association, with inconclusive and conflicting results. The study will be prospective in design, based on reference clinical/diagnostic criteria and functional neuroimaging.

Conditions

TMJ Disorder

Outcome Measures

Primary Outcomes (1)

• fmri Blood Oxygen Level-Dependent (BOLD)

  Oxygenation concentration (referred to as BOLD). Bold is primarily used on the other hand to conduct function brain mapping. The degree of BOLD is a measure of the neuronal activity.

  end of the fmri

Study Arms (2)

study

EXPERIMENTAL

FMRI

Diagnostic Test: fMRI

Healthy controls

ACTIVE COMPARATOR

FMRI

Diagnostic Test: fMRI

Interventions

fMRI DIAGNOSTIC_TEST

fMRI morphological analysis

Healthy controls; study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Afflicted with temporomandibular disorder (TMD) associated with chronic pain diagnosed by an experienced specialist among the authors; the disorder, to be considered chronic, must have been present for at least six months.
• Patients with adequate sensorimotor abilities to participate in the study. This included sufficient vision to read from a computer or tablet screen at a normal distance, sufficient hearing ability to understand normal language, and sufficient motor ability to control a table mouse or computer.

You may not qualify if:

• Healthy subjects defined as free from temporomandibular disorders or diagnosed psychological and/or psychiatric disorders.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

University of Milan

Milan, Italy

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Gianluca Tartaglia GMT Tartaglia

CONTACT

+39 02 5032 5032; gio.cat@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CO-Principal Investigator

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

IT (1)