Clinical trial NCT04120129: Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
Official title: An Investigation of Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Pain
Keywords: trigmenial neuralgia
Chronic orofacial pain
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TMS, sham-TMS, and no treatment groups
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changed Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)
timeFrame: 7 months
Secondary outcomes:
measure: Length of altered pain
timeFrame: 7 months
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Institute for Orthopedics and Neurosciences
state: Virginia
Study officials:
affiliation: Surgeon
name: Mark Witcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: