Transcranial Magnetic Stimulation (TMS) for Trigeminal Neuralgia
NCT ID: NCT04120129
Last Updated: 2020-11-13
Study Results
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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UNKNOWN
NA
51 participants
INTERVENTIONAL
2020-08-01
2021-06-30
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TMS treatment
participants receive TMS treatment
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
participants receive control TMS treatment
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.
non intervention
control group
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Carilion Clinic
OTHER
Responsible Party
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Mark Witcher
Neurosurgeon
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
Countries
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Central Contacts
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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