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N/A N=9 Treatment

Transcranial Magnetic Stimulation for Facial Pain

Trigeminal Nerve Injuries · Post-herpetic Neuralgia · Facial Pain · Nervus Intermedius Neuralgia

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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