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Transcranial Magnetic Stimulation for Facial Pain

Primary Purpose

Trigeminal Nerve Injuries, Post-herpetic Neuralgia, Facial Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Nerve Injuries focused on measuring trigeminal region pain

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Magnetic Stimulation

Arm Description

transcranial magnetic stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 10, 2015
Last Updated
March 15, 2021
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02633306
Brief Title
Transcranial Magnetic Stimulation for Facial Pain
Official Title
Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Nerve Injuries, Post-herpetic Neuralgia, Facial Pain, Nervus Intermedius Neuralgia
Keywords
trigeminal region pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Experimental
Arm Description
transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall
Description
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.
Time Frame
pre-treatment, 3 and 7 days post treatment
Title
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health
Description
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.
Time Frame
baseline, 3 and 7 days post treatment
Title
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health
Description
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.
Time Frame
baseline, 3 and 7 days post treatment
Title
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships
Description
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.
Time Frame
baseline, 3 and 7 days post treatment
Title
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment
Description
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.
Time Frame
baseline, 3 and 7 days post treatment
Other Pre-specified Outcome Measures:
Title
Young Mania Rating Scale (YMRS)
Description
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.
Time Frame
pre-treatment, 3 and 7 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Haines, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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