Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia

NCT ID: NCT04120129

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Facial Pain

Keywords

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trigmenial neuralgia Chronic orofacial pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

TMS, sham-TMS, and no treatment groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
TMS and sham TMS treatment group participants and researchers will be blinded to which treatment the participant receives

Study Groups

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TMS treatment

participants receive TMS treatment

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

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.

sham TMS

participants receive control TMS treatment

Group Type SHAM_COMPARATOR

sham TMS coil

Intervention Type DEVICE

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.

non intervention

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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TMS coil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carilion Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark Witcher

Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Witcher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Surgeon

Locations

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Institute for Orthopedics and Neurosciences

Roanoke, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mark Witcher, MD, PhD

Role: CONTACT

Phone: 540-224-5170

Email: [email protected]

Mallory Blackwood, MS

Role: CONTACT

Phone: 8047542825

Email: [email protected]

Facility Contacts

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Jordan Darden, PhD

Role: primary

Other Identifiers

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19-371

Identifier Type: -

Identifier Source: org_study_id