Temporomandibular Joint DisordersNCT02247063
Motor Cortex as a Research & Therapeutic Target in TMD
A study testing High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in people with Temporomandibular Joint Disorders, run by University of Michigan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Motor Cortex as a Research and Therapeutic Target in TMD
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Definition Transcranial Direct Current Stimulation (HD-tDCS)Device
HD-tDCS is a non-invasive brain neuromodulatory method for M1 that involves sending a weak electrical current into your brain.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Sham comparator | 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. Receives: Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS) |
| Experimental | 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. Receives: Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Post tDCS sessions compared to baseline (one week)
Secondary outcomes (1)
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)
Measured: One month after tDCS sessions compared to baseline (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre DaSilva, DDS, DMedSc, University of Michigan
- Investigators
- Alexandre FM DaSilva, DDS, DMedSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247063
- Sponsor's protocol ID
- 70766
- Status last verified
- Mar 2020
- First submitted
- 18 Sep 2014
- Last updated
- 1 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Cortex as a Research and Therapeutic Target in TMD
- ClinicalTrials.gov ID
- NCT02247063
- Acronym / sponsor ID
- 70766
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Posted 6 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Sham comparator | Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS)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. |
| Experimental | Experimental | Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Definition Transcranial Direct Current Stimulation (HD-tDCS)HD-tDCS is a non-invasive brain neuromodulatory method for M1 that involves sending a weak electrical current into your brain. | Device | Experimental, Placebo |
Primary outcome
Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
Time frame: Post tDCS sessions compared to baseline (one week)
Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
1 secondary outcome
Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
Time frame: One month after tDCS sessions compared to baseline (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre FM DaSilva, DDS, DMedSc principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in people with Temporomandibular Joint Disorders, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline (time frame: Post tDCS sessions compared to baseline (one week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.