Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2026-01-26 @ 11:31 AM
Study NCT ID:
NCT02633306
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Magnetic Stimulation for Facial Pain
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: