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Motor Cortex as a Research & Therapeutic Target in TMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247063
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandre DaSilva, DDS, MS, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Motor Cortex as a Research and Therapeutic Target in TMD
Study Start Date : September 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: 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.
Device: 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.

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.
Device: 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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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) ]
    Self-reported VAS from 0 (no pain) to 10 (worst possible pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247063


Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Alexandre FM DaSilva, DDS, DMedSc University of Michigan

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Responsible Party: Alexandre DaSilva, DDS, MS, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02247063    
Other Study ID Numbers: 70766
First Posted: September 23, 2014    Key Record Dates
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes