Status:
UNKNOWN
Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
Lead Sponsor:
Carilion Clinic
Conditions:
Facial Pain
Eligibility:
All Genders
18-100 years
Phase:
NA
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 se...
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 dur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04120129
Start Date
August 1 2020
End Date
June 1 2021
Last Update
November 13 2020
Active Locations (1)
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1
Institute for Orthopedics and Neurosciences
Roanoke, Virginia, United States, 24014