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Clinical Trials/NCT07259902
NCT07259902
Not yet recruiting
Not Applicable

Mapping the Neuroplasticity of Patients Affected by Chronic Temporomandibular Disorders on fMRI

University of Milan1 site in 1 country60 target enrollmentStarted: January 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
fmri Blood Oxygen Level-Dependent (BOLD)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Control subjects, participating voluntarily in the study, must have met the following inclusion criteria:
  • Healthy subjects defined as free from temporomandibular disorders or diagnosed psychological and/or psychiatric disorders.

Outcomes

Primary Outcomes

fmri Blood Oxygen Level-Dependent (BOLD)

Time Frame: end of the fmri

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marco Farronato

CO-Principal Investigator

University of Milan

Study Sites (1)

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