FMRI Study on DC/TMD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fMRI.
- Who it may be relevant to
- Registry conditions: TMJ Disorder. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mapping the Neuroplasticity of Patients Affected by Chronic Temporomandibular Disorders on fMRI
Overview
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.
Interventions
- Diagnostic test fMRI
fMRI morphological analysis
Primary outcome measures
- fmri Blood Oxygen Level-Dependent (BOLD) [Time frame: end of the fmri]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- University of Milan — Milan
Identifiers
NCT: NCT07259902 · DC/TMD01