Transcranial Magnetic Stimulation for Facial Pain

Completed · Not applicable

Conditions studied: Trigeminal Nerve Injuries, Post-herpetic Neuralgia, Facial Pain, Nervus Intermedius Neuralgia

In brief

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.

Key facts

Study ID: NCT02633306
Run by: University of Minnesota
People needed: 9
Starts: 2016-08-01
Expected to finish: 2019-08-30
Last updated by the study team: 2021-04-08

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
Subject cannot pass the TMS Adult Safety Screen or the CMRR Safety Screen.
Subject has severe and frequent headaches not part of their facial pain syndrome.
Subject has a history of significant hearing loss.
Subjects with a significant neurological disorder or insult including, but not limited to:
Any condition likely to be associated with increased intracranial pressure
Space occupying brain lesion
History of cerebrovascular accident
Transient ischemic attack within two years
Cerebral aneurysm
MMSE ≤ 24
Parkinson's disease
Huntington's chorea
Multiple sclerosis
Subject with a history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
Inadequate communication with the patient.
Subject is under custodial care.
Subject is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
Subject with unstable physical disease such as unstable cardiac disease.
Subject is currently on Benzodiazepine at a dose higher than 3 mg of Lorazepam or equivalent.

Where it is running

University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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