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Trial record 1 of 3 for:    herpes zoster oticus
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Transcranial Magnetic Stimulation for Facial Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633306
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Trigeminal Nerve Injuries Post-herpetic Neuralgia Facial Pain Nervus Intermedius Neuralgia Device: transcranial magnetic stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complex Oro-Facial Pain: Functional Imaging Characterization and Treatment With Transcranial Magnetic Stimulation
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. visual analogue scale (VAS) [ Time Frame: change from pre-treatment to 7 days post treatment ]
    10 cm visual analogue scale with 0 representing no pain and 10 representing worst possible pain


Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: pre-treatment, 3 and 7 days post treatment ]
    a multiple item questionnaire to indicate depression and evaluate recovery in adults. The questions cover mood, activity level, sleep/insomnia, weight loss, anxiety, agitation, suicidality, guilt, and somatic symptoms.

  2. World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) [ Time Frame: 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.


Other Outcome Measures:
  1. Beck Scale for Suicide Ideation [ Time Frame: pre-treatment, 3 and 7 days post treatment ]
    The Beck Scale for Suicide Ideation (BSI) is a 21-item self-report questionnaire developed by Aaron Beck to quantify the severity of suicidal ideation. The items on this scale measure the participant's specific attitudes, behaviors, and plans to commit suicide on the day of the interview.

  2. Young Mania Rating Scale (YMRS) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633306


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Stephen J Haines, MD University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02633306    
Other Study ID Numbers: 1511M80284
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
trigeminal region pain
Additional relevant MeSH terms:
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Herpes Zoster Oticus
Herpes Zoster
Varicella Zoster Virus Infection
Trigeminal Nerve Injuries
Neuralgia
Neuralgia, Postherpetic
Facies
Facial Pain
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Cranial Nerve Diseases
Trigeminal Nerve Diseases
Facial Neuralgia
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System