CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
transcranial magnetic stimulationdevice
Likely dose
Transcranial magnetic stimulation of motor cortex, five daily sessions, contralateral to painAI-extracted
Key inclusion· 4
  • ✓Age 18–110 years old
  • ✓Confirmed diagnosis of complex oro-facial pain by UMPhysicians Complex Facial Pain Clinic
  • ✓Specific facial pain condition: trigeminal neuralgia Type 2, trigeminal neuropathic pain, trigeminal deafferentation pain, post-herpetic neuralgia, atypical facial pain, or nervus intermedius neuralgia
  • ✓No available alternative treatment of proven value as judged by UMPhysicians Complex Facial Pain Clinic
Key exclusion· 16
  • ✕Major Axis I psychiatric disorder (psychotic disorder, bipolar disorder, OCD; major depressive disorder allowed if Hamilton Depression Rating Scale-21 ≤26 or Beck Depression Inventory score controlled)
  • ✕Significant suicidal risk assessed by Beck Suicide Ideation scale, psychiatric interview, or attempted suicide in past year
  • ✕History of epilepsy or seizure (except those induced by ECT)
  • ✕Significant head trauma with loss of consciousness >5 minutes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02633306
NCT02633306N/ACompleted
CompareCT.gov

Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation

University of Minnesota·interventional·Posted Dec 17, 2015·Updated Apr 8, 2021

In Brief

A clinical study evaluating transcranial magnetic stimulation for Trigeminal Nerve Injuries and 3 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrigeminal Nerve Injuries, Post-herpetic Neuralgia, Facial Pain, Nervus Intermedius Neuralgia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 17, 2015
Enrollment StartAug 1, 2016
Primary CompletionJul 1, 2019
Study CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.5 years ago

Interventions

transcranial magnetic stimulationdevice

Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.