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

An Investigation of Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)

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.

Study Overview

• Status: Unknown
• Conditions: Facial Pain
• Intervention / Treatment: Device: TMS; Device: sham TMS coil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Witcher, MD, PhD; Phone Number: 540-224-5170; Email: mrwitcher@carilionclinic.org
• Study Contact Backup: Name: Mallory Blackwood, MS; Phone Number: 8047542825; Email: bmal@vt.edu

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Institute for Orthopedics and Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changed Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)	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. The scale asks participants to identify their pain level across body areas and total from 0-10 (0 being none & 10 worst possible)	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of altered pain	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. The scale asks participants to identify their pain level across body areas and total from 0-10 (0 being none & 10 worst possible)	7 months

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Mark Witcher, MD, PhD, Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: trigmenial neuralgia; Chronic orofacial pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Facial Pain; Trigeminal Neuralgia
• Other Study ID Numbers: 19-371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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