Facial Pain, Nervus Intermedius Neuralgia, Post-herpetic Neuralgia, Trigeminal Nerve Injuries
Conditions
Keywords
trigeminal region pain
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. 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.
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.
Interventions
DEVICEtranscranial magnetic stimulation
Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | 7 days | 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
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall | 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. 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 | baseline, 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. 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 | baseline, 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. 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 | baseline, 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. 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 | baseline, 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. 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Young Mania Rating Scale (YMRS) | 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. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Transcranial Magnetic Stimulation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Magnetic Stimulation | Visual Analogue Scale (VAS) | 5.4 score on a scale | Standard Deviation 11.7 |
Comparison: In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.
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.
Time frame: baseline, 3 and 7 days post treatment
Population: All enrolled patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment | baseline | 37 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment | 3 days post-treatment | 37 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment | 7 days post-treatment | 38 score on a scale |
Comparison: In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.
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.
Time frame: pre-treatment, 3 and 7 days post treatment
Population: All enrolled patients for whom any data was acquired are included.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall | pre-treatment baseline | 5 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall | 3 days post-treatment | 5 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall | 7 days post-treatment | 5 score on a scale |
Comparison: In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.
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.
Time frame: baseline, 3 and 7 days post treatment
Population: All enrolled patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health | baseline | 19 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health | 3 days post-treatment | 18.5 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health | 7 days post-treatment | 17 score on a scale |
Comparison: In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.
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.
Time frame: baseline, 3 and 7 days post treatment
Population: All enrolled patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health | baseline | 23 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health | 3 days post-treatment | 22 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health | 7 days post-treatment | 25 score on a scale |
Comparison: In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.
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.
Time frame: baseline, 3 and 7 days post treatment
Population: All enrolled patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships | baseline | 13 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships | 3 days post-treatment | 13 score on a scale |
| Transcranial Magnetic Stimulation | World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships | 7 days post-treatment | 13.5 score on a scale |
Comparison: In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.
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.
Time frame: pre-treatment, 3 and 7 days post treatment
Population: all enrolled patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Transcranial Magnetic Stimulation | Young Mania Rating Scale (YMRS) | baseline | 0 score on a scale |
| Transcranial Magnetic Stimulation | Young Mania Rating Scale (YMRS) | 3 days post treatment | 0 score on a scale |
| Transcranial Magnetic Stimulation | Young Mania Rating Scale (YMRS) | 7 days post treatment | 0 score on a scale |
Comparison: In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.