NCT02633306

Transcranial Magnetic Stimulation for Facial Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-07-01
• Completion: 2019-08-30
• First posted: 2015-12-17
• Last updated: 2021-04-08
• Results posted: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study