Transcranial Magnetic Stimulation for Facial Pain

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

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 Overview

• Status: Completed
• Conditions: Facial Pain; Trigeminal Nerve Injuries; Post-herpetic Neuralgia; Nervus Intermedius Neuralgia
• Intervention / Treatment: Device: transcranial magnetic stimulation

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Participants are asked to rate pain on a100 mm visual analogue scale with 0 representing no pain and 100 representing worst possible pain. The mean difference from baseline to 7 days post-treatment is recorded.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall	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. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.	pre-treatment, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health	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. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.	baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health	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. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.	baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships	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. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.	baseline, 3 and 7 days post treatment
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment	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. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.	baseline, 3 and 7 days post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Young Mania Rating Scale (YMRS)	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. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.	pre-treatment, 3 and 7 days post treatment

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Stephen J Haines, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: trigeminal region pain
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Pain; Neurologic Manifestations; Wounds and Injuries; Disease Attributes; Neuromuscular Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; DNA Virus Infections; Ear Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Herpesviridae Infections; Varicella Zoster Virus Infection; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Cranial Nerve Injuries; Herpes Zoster; Neuralgia; Facial Pain; Neuralgia, Postherpetic; Facies; Herpes Zoster Oticus; Trigeminal Nerve Injuries
• Other Study ID Numbers: 1511M80284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes