Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia

Last updated: November 10, 2020
Sponsor: Carilion Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Pain (Pediatric)

Trigeminal Neuralgia

Treatment

N/A

Clinical Study ID

NCT04120129
19-371
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of classic trigeminal neuralgia or persisten idiopathic facialpain
  • Considered an appropriate candidate for surgical or stereotactic intervention -microvascular decompression or stereotactic radiosurgery- ( includes factors such asoverall 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

Exclusion Criteria:

  • Multiple Sclerosis or trauma-related etiology of facial pain (i.e. secondary facialpain)

  • contraindication to TMS, per device guidelines: Metallic implant in or near head Implanted stimulator on or near head recent suicidalideation history of epilepsy, stroke, or unexplained seizure

  • Need for urgent/emergent surgical decompression.

Study Design

Total Participants: 51
Study Start date:
August 01, 2020
Estimated Completion Date:
June 30, 2021

Study 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.

Connect with a study center

  • Institute for Orthopedics and Neurosciences

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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