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Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120129
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Witcher, Carilion Clinic

Brief Summary:
The primary objective is to establish the feasibility of using TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who recieved TMS at several timepoints.

Condition or disease Intervention/treatment Phase
Facial Pain Device: TMS Device: sham TMS coil Not Applicable

Detailed Description:

Participants will be randomized to either receive transcranial magnetic stimulation (TMS), Sham-TMS (a non-therapeutic TMS coil which sounds and feels similar to normal TMS), or standard treatment during the weeks of wait time before surgery for chronic orofacial pain (COFP). TMS is a noninvasive, painless magnetic device which, when applied to the head for a few minutes, has been shown to reduce pain in people with COFP. The sham TMS is a sub-therapeutic level of magnetcic stimulation which makes the same sound as normal TMS and causes a similar tingling of the skin.

Both those who receive this new pain intervention and those who do not will be asked to fill out a short online survey about their pain at several points during the study. The survey takes about 10 minutes to fill out and each of the 5 TMS sessions last 10 minutes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: TMS, sham-TMS, and no treatment groups
Masking: Double (Participant, Investigator)
Masking Description: TMS and sham TMS treatment group participants and researchers will be blinded to which treatment the participant receives
Primary Purpose: Treatment
Official Title: An Investigation of Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TMS treatment
participants receive TMS treatment
Device: TMS
Transcranial Magnetic Stimulation (TMS) is a noninvasive brain stimulation technique which produces short pulsatile magnetic fields (similar to that of an MRI) via two extracranial, figure 8-shaped electric coils which can induce a small, temporary, electric current in the brain currently approved and used for depression.
Other Name: TMS coil

Sham Comparator: sham TMS
participants receive control TMS treatment
Device: sham TMS coil
The sham TMS does cause some stimulation to the participant so that the participants get the sensation of treatment without any cortical excitation that TMS delivers. The sensation experienced is similar to the muscle twitching or finger tapping experienced by TMS participants.

No Intervention: non intervention
control group



Primary Outcome Measures :
  1. Decreased Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) [ Time Frame: 7 months ]
    The primary objective is to establish the effectiveness of TMS for COFP pain management in the interim period before surgery. This will be investigated by comparing the non-intervention group's self-reported pain to those who received TMS at several timepoints. Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)will be used.


Secondary Outcome Measures :
  1. Length of decreased pain [ Time Frame: 7 months ]
    A secondary objective is to establish how long the effects of TMS last. This will be done by comparing self-reported pain scores prior to TMS, after TMS and at several timepoints thereafter in those who recieved the treatment. Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) will be used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of classic trigeminal neuralgia or persisten idiopathic facial pain
  • Considered an appropriate candidate for surgical or stereotactic intervention - microvascular decompression or stereotactic radiosurgery- ( includes factors such as overall health, chronic medication, comorbidities) and patient preference
  • Between ages 18-100
  • Able to participate in 5 consecutive TMS treatments
  • Has at least 3 weeks between pre-op visit and scheduled date of surgery
  • Able to provide consent and complete online questionnaires on their own

Exclusion Criteria:

  • Multiple Sclerosis or trauma-related etiology of facial pain (i.e. secondary facial pain)
  • contraindication to TMS, per device guidelines:

Metallic implant in or near head Implanted stimulator on or near head recent suicidal ideation history of epilepsy, stroke, or unexplained seizure

- Need for urgent/emergent surgical decompression.


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): NCT04120129


Contacts
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Contact: Mark Witcher, MD, PhD 540-224-5170 mrwitcher@carilionclinic.org
Contact: Mallory Blackwood, MS 8047542825 bmal@vt.edu

Sponsors and Collaborators
Carilion Clinic
Investigators
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Principal Investigator: Mark Witcher, MD, PhD Surgeon

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Responsible Party: Mark Witcher, Neurosurgeon, Carilion Clinic
ClinicalTrials.gov Identifier: NCT04120129    
Other Study ID Numbers: 19-371
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 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: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mark Witcher, Carilion Clinic:
trigmenial neuralgia
Chronic orofacial pain
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Facial Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases