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Motor Cortex as a Research & Therapeutic Target in TMD

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Placebo

    Experimental

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    September 18, 2014
    Last Updated
    March 23, 2020
    Sponsor
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02247063
    Brief Title
    Motor Cortex as a Research & Therapeutic Target in TMD
    Official Title
    Motor Cortex as a Research and Therapeutic Target in TMD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Joint Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
    Intervention Description
    HD-tDCS is a non-invasive brain neuromodulatory method for M1 that involves sending a weak electrical current into your brain.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
    Description
    Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
    Time Frame
    Post tDCS sessions compared to baseline (one week)
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline
    Description
    Self-reported VAS from 0 (no pain) to 10 (worst possible pain)
    Time Frame
    One month after tDCS sessions compared to baseline (6 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandre FM DaSilva, DDS, DMedSc
    Organizational Affiliation
    University of Michigan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Motor Cortex as a Research & Therapeutic Target in TMD

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