Motor Cortex as a Research & Therapeutic Target in TMD

NCT02247063 | Completed Results

• 1 other identifier: 70766
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary 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)

  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

  One month after tDCS sessions compared to baseline (6 weeks)

Study Arms (2)

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.

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.

Device: High-Definition Transcranial Direct Current Stimulation (HD-tDCS)

Interventions

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.

Experimental; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Thiago Nascimento
• Organization: University of Michigan

Nasci@umich.edu

734-615-9390

Study Officials

• Alexandre FM DaSilva, DDS, DMedSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 23, 2014
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 1, 2020
• Results First Posted: December 6, 2017

Record last verified: 2020-03