Temporomandibular Joint Disorders
Conditions
Brief summary
The investigators are doing a study to learn about the effects of a type of low-energy non-surgical electrical brain stimulation (HD-tDCS) on chronic pain in people's jaw joints. Disorders in these joints are called temporomandibular joint disorders, or TMD.
Detailed description
Chronic temporomandibular joint disorders (TMD) represent clinical problems in which empirical treatments offer uncertain relief for a large number of patients. Many conventional therapies are ineffectual, leading to persistent treatment failure and/or poor iatrogenic-induced results; which raises the possibility that the cause for their pain endurance may also lie in the brain milieu. Although MRI-based techniques have provided insights into some neuroplastic mechanisms of TMD in humans, many questions regarding its molecular mechanisms in vivo are still unanswered. First, how are endogenous μ-opioid mechanisms in the brain, known to be centrally involved in pain regulation, affected by acute and chronic TMD pain? Second, how can they be directly modulated to provide analgesic effect on pain measures? Finally, what are the neuroplastic effects in the brain after continuous modulation of those molecular mechanisms? The understanding of these processes is crucial to determine the mechanisms engaged in the persistence and, most important, the alleviation of TMD. Preliminary studies from our center, using positron emission tomography (PET) with \[11C\] carfentanil, a selective radiotracer for mu-opioid receptor (muOR), have demonstrated that there is a decrease in μOR availability (non-displaceable binding potential -BPND) in key pain-related structures in the brains of chronic trigeminal pain patients, which correlated with their clinical pain measures. We propose to demonstrate that acute (masseteric pain challenge) and chronic clinical pain measures in TMD patients are correlated with μ-opioid receptor (µOR) non-displaceable binding potential (BPND) in the thalamus and other pain-related regions.
Interventions
HD-tDCS is a non-invasive brain neuromodulatory method for M1 that involves sending a weak electrical current into your brain.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Daily chronic TMD pain and dysfunction for at least one year (Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I Group I: Myofascial pain diagnosis\[15\]) not adequately controlled by previous conventional therapies (TMJ open-surgery naïve) for more than 1 year * Self-reported pain score of at least 3 on a 0-10 scale in spite of existing treatment in the two weeks preceding the onset of the study * Taking stable doses of medications for at least 4 weeks (if taking medications), and willing to limit the introduction of new medications for chronic TMD symptoms during the study
Exclusion criteria
* Pain not primarily due to TMD * History or current evidence of a psychotic disorder (e.g. schizophrenia) or substance abuse by DSM-IV criteria; bipolar or severe major depression * History of neurological disorder (e.g. epilepsy, stroke, neuropathy, neuropathic pain) * Any severe clinical condition that in the opinion of the principal investigator interferes with the study * Pregnant or expecting to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline | Post tDCS sessions compared to baseline (one week) | Self-reported VAS from 0 (no pain) to 10 (worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline | One month after tDCS sessions compared to baseline (6 weeks) | Self-reported VAS from 0 (no pain) to 10 (worst possible pain) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo The subjects in the placebo arm will participate in 5 daily M1 High-Definition Transcranial Direct Current Stimulation (HD-tDCS) sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Current will be applied only for 30 seconds - this is a reliable method of sham stimulation (Gandiga et al., 2006) as sensations arising from tDCS treatment occur only at the beginning of application.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain. | 12 |
| Experimental The subjects in the experimental arm will participate in 5 daily sessions. During each session, a modular EEG recording cap will be placed on the subject's head and the anodal electrode will be placed on the motor cortex contralateral to the worst TMD pain side (C3). Then 2mA of transcranial direct current stimulation will be applied for 20 minutes.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS): HD-tDCS is a non-invasive brain neuromodulatory method for M1that involves sending a weak electrical current into your brain. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | Placebo | Experimental |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 12 Participants | 12 Participants |
| Age, Continuous | 35.2 years STANDARD_DEVIATION 15 | 35.6 years STANDARD_DEVIATION 16.7 | 34.8 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 24 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 24 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 12 / 12 | 12 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
Time frame: Post tDCS sessions compared to baseline (one week)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline | 4 participants |
| Experimental | Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline | 9 participants |
Secondary
Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
Time frame: One month after tDCS sessions compared to baseline (6 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline | 4 participants |
| Experimental | Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline | 9 participants |