TGN: Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia

Sponsor

Carilion Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04120129

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

TMS, sham-TMS, and no treatment groupsTMS, 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)

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Length of altered pain [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. The scale asks participants to identify their pain level across body areas and total from 0-10 (0 being none & 10 worst possible)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Orthopedics and Neurosciences	Roanoke	Virginia	United States	24014

Sponsors and Collaborators

Carilion Clinic

Investigators

Principal Investigator: Mark Witcher, MD, PhD, Surgeon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mark Witcher, Neurosurgeon, Carilion Clinic

ClinicalTrials.gov Identifier:

NCT04120129

Other Study ID Numbers:

19-371

First Posted:

Oct 9, 2019

Last Update Posted:

Nov 13, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mark Witcher, Neurosurgeon, Carilion Clinic

trigmenial neuralgia

Chronic orofacial pain

Additional relevant MeSH terms:

Trigeminal Neuralgia

Neuralgia

Facial Pain

Study Results

No Results Posted as of Nov 13, 2020