Recruiting

TMS

Sponsor:

Carilion Clinic

Code:

NCT04120129

Conditions

Facial Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TMS

sham TMS coil

Study Details

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.

Conditions

Facial Pain

Study ID

NCT04120129

Start date

Aug 1, 2020

Status verified date

Nov, 2020

Completion date

Jun, 2021

Anticipated

Primary completion date

Feb, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

51 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TMS treatment

participants receive TMS treatment

sham comparator: sham TMS

participants receive control TMS treatment

no intervention: non intervention

control group

Interventions

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.

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.

Primary outcome measure

  • Changed Pain assessed by self reported measures: Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) [ Time Frame: 7 months ]

Central Contacts and Locations

Central contacts

Mark Witcher, MD, PhD

540-224-5170mrwitcher@carilionclinic.org

Mallory Blackwood, MS

8047542825bmal@vt.edu

Locations

Institute for Orthopedics and Neurosciences

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Jordan Darden, PhD

540-981-7942jadarden@carilionclinic.org

More Information

Sponsor

Carilion Clinic

Last update posted

Nov 13, 2020

Last verified

Nov, 2020

Keywords

  • trigmenial neuralgia
  • Chronic orofacial pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2020-11-13.