Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
95 Participants
are grouped into 4 trial groupsGroup A: Low-impact chronic painful temporomandibular disorder (TMD) cases
Group B: High- impact chronic painful temporomandibular disorder (TMD) cases
Group C: Pain-free controls
Group D: Pilot study-MRI optimization group
Trial outcomes
Primary outcomes
1
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.
Time frame
2.5 hours2
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.
Time frame
2.5 hours3
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.
Time frame
2.5 hours4
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.
Time frame
2.5 hoursSecondary outcomes
1
Temporal Summation of Pain (TSP) and Conditioned Pain Modulation (CPM) responses
To assess correlations between functional connectivity and anatomical connectivity matrices and individual endogenous pain modulation responses, TSP and CPM testing will be conducted. TSP testing uses a thermal device and custom pressure algometers to deliver a single stimulus perceived as "slightly painful" by the participant, followed by 5- or 10-stimuli series repeated at 1 Hz. CPM testing uses a pressure algometer as test stimulus to deliver increasing pressure (50kPa/s rate) to the test site until the participant presses a switch signaling when the pressure sensation first becomes painful. The conditioning stimulus (CS) used to elicit pain inhibition for CPM testing is tonic noxious contact heat applied to the non-dominant volar forearm. CPM testing is also done in triplicate on two occasions: at baseline and during CS applied to the forearm. TSP and CPM responses will be assessed during Visit 2 of the study and reported as percentage values.
Time frame
3.5 hoursSponsors and contacts
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Source ClinicalTrials.gov