Clinical trial NCT02633306: Transcranial Magnetic Stimulation for Facial Pain
Official title: Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Nerve Injuries
Post-herpetic Neuralgia
Facial Pain
Nervus Intermedius Neuralgia
Keywords: trigeminal region pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Methods: Patients diagnosed with complex oral or facial pain at the UMPhysicians Complex Facial Pain Clinic who meet inclusion and exclusion criteria will be offered participation in the study. They will undergo baseline evaluation for depression with the HAM-D and MADRAS scales and for quality of life with the WHOQOL-BREF scale. Pain will be assessed using a 10 point visual analogue scale. Resting and pcasl MRI will be done within 24 hours before the first treatment. Treatment will consist of five daily sessions of motor cortex stimulation contralateral to the pain. Visual analogue pain scores will be obtained just before each treatment. Rating scales, resting and pcasl MRI will be repeated within 24 hours and at 2 weeks after the last treatment. Analysis: FMRI activation patterns will be examined by the investigators and correlated with treatment outcomes with the goal of identifying fMRI characteristics that can select patients suitable for further study.

Eligibility criteria: 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 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.
* Subject has had previous treatment with TMS.
* Women who are breast-feeding.
* Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
* Inability to give informed consent

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall
timeFrame: pre-treatment, 3 and 7 days post treatment
measure: World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health
timeFrame: baseline, 3 and 7 days post treatment
measure: World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health
timeFrame: baseline, 3 and 7 days post treatment
measure: World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships
timeFrame: baseline, 3 and 7 days post treatment
measure: World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment
timeFrame: baseline, 3 and 7 days post treatment
Other outcomes:
measure: Young Mania Rating Scale (YMRS)
timeFrame: pre-treatment, 3 and 7 days post treatment
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Stephen J Haines, MD
role: PRINCIPAL_INVESTIGATOR
References: