Transcranial Magnetic Stimulation for Facial Pain

NCT02633306 | Completed Results FDA Device

• 1 other identifier: 1511M80284
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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. 1.To establish baseline patterns of MRI in patients with chronic oro-facial pain without a definitive etiologic diagnosis.
2. 2.To estimate the rate of treatment success of transcranial stimulation of the primary motor cortex (M1) in these patients.
3. 3.To identify post-treatment MRI patterns that are associated with treatment success.

Conditions

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

Keywords

trigeminal region pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall

  pre-treatment, 3 and 7 days post treatment

• World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health

  baseline, 3 and 7 days post treatment

• World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health

  baseline, 3 and 7 days post treatment

• World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships

  baseline, 3 and 7 days post treatment

• World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment

  baseline, 3 and 7 days post treatment

Other Outcomes (1)

• Young Mania Rating Scale (YMRS)

  pre-treatment, 3 and 7 days post treatment

Study Arms (1)

Transcranial Magnetic Stimulation

EXPERIMENTAL

transcranial magnetic stimulation

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

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

Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Trigeminal Nerve Injuries; Neuralgia, Postherpetic; Facial Pain; Myoclonic Cerebellar Dyssynergia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinocerebellar Degenerations; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Stephen Haines, MD
• Organization: University of Minenesota

shaines@umn.edu

612 624-6666

Study Officials

• Stephen J Haines, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 30, 2019
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)