Transcranial Magnetic Stimulation for Facial Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02633306|
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : October 8, 2019
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.
- To establish baseline patterns of MRI in patients with chronic oro-facial pain without a definitive etiologic diagnosis.
- To estimate the rate of treatment success of transcranial stimulation of the primary motor cortex (M1) in these patients.
- To identify post-treatment MRI patterns that are associated with treatment success.
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Nerve Injuries Post-herpetic Neuralgia Facial Pain Nervus Intermedius Neuralgia||Device: transcranial magnetic stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.|
|Masking:||None (Open Label)|
|Official Title:||Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation|
|Actual Study Start Date :||August 1, 2016|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||August 30, 2019|
Experimental: Transcranial Magnetic Stimulation
transcranial magnetic stimulation
Device: transcranial magnetic stimulation
Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
- visual analogue scale (VAS) [ Time Frame: change from pre-treatment to 7 days post treatment ]10 cm visual analogue scale with 0 representing no pain and 10 representing worst possible pain
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: pre-treatment, 3 and 7 days post treatment ]a multiple item questionnaire to indicate depression and evaluate recovery in adults. The questions cover mood, activity level, sleep/insomnia, weight loss, anxiety, agitation, suicidality, guilt, and somatic symptoms.
- World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) [ Time Frame: pre-treatment, 3 and 7 days post treatment ]A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment.
- Beck Scale for Suicide Ideation [ Time Frame: pre-treatment, 3 and 7 days post treatment ]The Beck Scale for Suicide Ideation (BSI) is a 21-item self-report questionnaire developed by Aaron Beck to quantify the severity of suicidal ideation. The items on this scale measure the participant's specific attitudes, behaviors, and plans to commit suicide on the day of the interview.
- Young Mania Rating Scale (YMRS) [ Time Frame: pre-treatment, 3 and 7 days post treatment ]The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633306
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Stephen J Haines, MD||University of Minnesota|