Back to resultsTranscranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)
Primary Purpose
Facial Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS
sham TMS coil
Sponsored by
About this trial
This is an interventional treatment trial for Facial Pain focused on measuring trigmenial neuralgia, Chronic orofacial pain
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.
Sites / Locations
- Institute for Orthopedics and NeurosciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
TMS treatment
sham TMS
non intervention
Arm Description
participants receive TMS treatment
participants receive control TMS treatment
control group
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04120129
Brief Title
Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
Acronym
TGN
Official Title
An Investigation of Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia (TGN)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Pain
Keywords
trigmenial neuralgia, Chronic orofacial pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
TMS, sham-TMS, and no treatment groups
Masking
ParticipantInvestigator
Masking Description
TMS and sham TMS treatment group participants and researchers will be blinded to which treatment the participant receives
Allocation
Randomized
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TMS treatment
Arm Type
Experimental
Arm Description
participants receive TMS treatment
Arm Title
sham TMS
Arm Type
Sham Comparator
Arm Description
participants receive control TMS treatment
Arm Title
non intervention
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
TMS
Other Intervention Name(s)
TMS coil
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham TMS coil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changed Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2)
Description
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)
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Length of altered pain
Description
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)
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Witcher, MD, PhD
Phone
540-224-5170
Email
mrwitcher@carilionclinic.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mallory Blackwood, MS
Phone
8047542825
Email
bmal@vt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Witcher, MD, PhD
Organizational Affiliation
Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Orthopedics and Neurosciences
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Darden, PhD
Phone
540-981-7942
Email
jadarden@carilionclinic.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
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