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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Magnetic Stimulation | Experimental | transcranial magnetic stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial magnetic stimulation | Device | Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain. |
|
| 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 |
| 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. |
| 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 |
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Haines, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Magnetic Stimulation | transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 of the 9 participants withdrew participant prior to the collection of baseline data. All 7 participants from whom data was collected are reported here.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Magnetic Stimulation | transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Three patients left the study before treatment. One of 6 patients who began treatment did not complete the full treatment regimen and therefore post treatment status could not be assessed. | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Magnetic Stimulation | transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Haines, MD | University of Minenesota | 612 624-6666 | shaines@umn.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2021 | Feb 12, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D061221 | Trigeminal Nerve Injuries |
| D051474 | Neuralgia, Postherpetic |
| D005157 | Facial Pain |
| D002527 | Myoclonic Cerebellar Dyssynergia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
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| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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. | All enrolled patients for whom any data was acquired are included. | Posted | Median | Full Range | score on a scale | pre-treatment, 3 and 7 days post treatment |
|
|
|
|
| Other Pre-specified | 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. | all enrolled patients | Posted | Median | Full Range | score on a scale | pre-treatment, 3 and 7 days post treatment |
|
|
|
|
| Secondary | 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. | All enrolled patients | Posted | Median | Full Range | score on a scale | baseline, 3 and 7 days post treatment |
|
|
|
|
| Secondary | 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. | All enrolled patients | Posted | Median | Full Range | score on a scale | baseline, 3 and 7 days post treatment |
|
|
|
|
| Secondary | 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. | All enrolled patients | Posted | Median | Full Range | score on a scale | baseline, 3 and 7 days post treatment |
|
|
|
|
| Secondary | 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. | All enrolled patients | Posted | Median | Full Range | score on a scale | baseline, 3 and 7 days post treatment |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| Tremors | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Non-specific Pain | General disorders | Systematic Assessment |
|
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| D009057 |
| Stomatognathic Diseases |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013132 | Spinocerebellar Degenerations |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
| 7 days post-treatment |
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| 7 days post treatment |
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| 7 days post-treatment |
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| 7 days post-treatment |
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| 7 days post-treatment |
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| 7 days post-treatment |
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