Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT03724032
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03724032
Study Brief:
Protocol Section:
NCT03724032