N/A
N=9
Transcranial Magnetic Stimulation for Facial Pain
Trigeminal Nerve Injuries · Post-herpetic Neuralgia · Facial Pain · Nervus Intermedius Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT02633306 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Visual Analogue Scale (VAS) — 5.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial magnetic stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS) |
5.4 | — |
| SECONDARY World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall |
5; 5; 5 | — |
| SECONDARY World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health |
19; 18.5; 17 | — |
| SECONDARY World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health |
23; 22; 25 | — |
| SECONDARY World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships |
13; 13; 13.5 | — |
| SECONDARY World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment |
37; 37; 38 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02633306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.