Transcranial Magnetic Stimulation for Facial Pain (NCT02633306) | Clinical Trial Compass
CompletedNot Applicable
Transcranial Magnetic Stimulation for Facial Pain
United States9 participantsStarted 2016-08-01
Plain-language summary
Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant suffering and disability. This study will explore the ability of fMRI to identify patients with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.
Specific Aims:
1. To establish baseline patterns of MRI in patients with chronic oro-facial pain without a definitive etiologic diagnosis.
2. To estimate the rate of treatment success of transcranial stimulation of the primary motor cortex (M1) in these patients.
3. To identify post-treatment MRI patterns that are associated with treatment success.
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 110
* Diagnosis of complex oro-facial pain made by the UMPhysicians Complex Facial Pain Clinic
* Alternative treatment of proven value not available as judged by the UMPhysicians Complex Facial Pain clinic
* One of the following types of facial pain as assessed by the Burchiel Patient Pain Rating Classification Questionnaire:
* trigeminal neuralgia Type 2 (TN2)
* trigeminal neuropathic pain (TNP)
* trigeminal deafferentation pain (TDP)
* post herpetic neuralgia (PHN)
* atypical facial pain (AFP)
* nervus intermedius neuralgia (NIN)
* Willing and able to give informed consent
Exclusion Criteria:
* Subject diagnosed according to the MINI as suffering from any other major Axis I disorder, such as Psychotic Disorder, Bipolar affective disorder, OCD (MDD is not contraindicated when Hamilton Depression Rating Scale -21≤26, or Beck Depression Inventory).
* Subjects with significant suicidal risk as assessed by the investigator using the Beck Suicide Ideation scale, psychiatric interview or a history of attempted suicide in the past year.
* Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
* Subject has a history of significant head trauma with loss of consciousness for longer than 5 minutes.
* Subject has a history of cranial surgery within 1 month of treatment.
* Subject has metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac li…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.