Investigation and Modulation of the Mu-opioid Mechanisms in TMD (in Vivo)

Stopped early · Not applicable · Has a placebo group

Conditions studied: Temporomandibular Disorder

In brief

In this study, this team of researchers will investigate the impact of chronic temporomandibular disorder suffering on the endogenous μ-opioid system in vivo, arguably one of the principal endogenous pain modulatory systems in the brain, and its modulation by 10 daily sessions of primary motor cortex stimulation using high-definition transcranial direct current stimulation (HD-tDCS).

Key facts

Study ID

NCT03724032

Run by

University of Michigan

People needed

15

Starts

2018-12-13

Expected to finish

2022-01-17

Last updated by the study team

2023-06-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide signed and dated informed consent form;
• Male or female, aged 18 to 65 (inclusive);
• tDCS naïve; and
• Willing to comply with all study procedures and be available for the duration of the study.
• In addition, TMD subjects must qualify as:
• Diagnosed with chronic TMD as defined by the Diagnostic Criteria (DC) for TMD and the American Academy of Orofacial Pain (DC/TMD): "Chronic TMD pain and dysfunction for at least one year from the clinical exam session (DC/TMD: Masticatory myofacial pain with/without referral) not adequately controlled by previous therapies (eg, NSAIDs, muscle relaxants)"
• TMJ open-surgery naïve;
• TMD maximum pain score pain of greater than or equal to 3 (moderate to severe) on a 0-10 VAS, despite existing treatment, for 3 days in the 7 days preceding study consent, based on report at the screening session;
• If taking pain medications, the dose regimen must be stable for at least 4 weeks prior to screening; and
• Willing to halt the introduction of new medications for chronic TMD symptoms during the study.
• Emphasis is therefore placed on generalizability and chronicity of symptoms.
• OR
• To qualify as a Healthy Volunteer, subjects must be:
• Without self-reported history of systemic disorders or other chronic pain disorders, including migraine.

You may not qualify if…

• Existence of chronic pain disorder(s) other than TMD
• History of a traumatic brain injury
• History or current evidence of a psychotic disorder (e.g. schizophrenia) or substance abuse (self-reported)
• Bipolar or severe major depression, as evidenced by a Beck Depression Inventory score of ≥ 30
• Ongoing, unresolved disability litigation (self-reported)
• History of neurological disorder (e.g. epilepsy, stroke, neuropathy, neuropathic pain; self-reported)
• Opioid pain medications taken within the past 3 months
• Past allergic response to opioids or chemically related drugs (e.g., carfentanil)
• Excluded by MRI Center or PET Center safety screening checklist (as administered by study staff)
• Drug test positive for opioid or recreational drug (e.g., cannabis) at the time of the PET scan visits
• Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)
• Treatment with an investigational drug, device or other intervention within 30 days of study enrollment
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study (e.g., medical condition, laboratory finding, physical exam finding, logistical complication).

Where it is running

• University of Michigan School of Dentistry — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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