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

Carilion Clinic

Status: Unknown

Conditions: Facial Pain

Treatments: Device: TMS; Device: sham TMS coil

Study type: Interventional

Funder types: Other

Identifiers

NCT04120129

19-371

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups

TMS treatment

Experimental group

Description:

participants receive TMS treatment

Treatment:

Device: TMS

sham TMS

Sham Comparator group

Description:

participants receive control TMS treatment

Treatment:

Device: sham TMS coil

non intervention

No Intervention group

Description:

control group