Status:
COMPLETED
Neurophysiologic Signatures of Trigeminal Neuralgia Pain
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Facial Pain Research Foundation
Conditions:
Trigeminal Neuralgia (TN)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Trigeminal neuralgia (TN) is an idiopathic pain disorder that is characterized by episodic attacks of intense facial pain, described as paroxysms of stabbing, electric, or explosive pain, and lasting ...
Detailed Description
Trigeminal neuralgia (TN) is an extremely painful and highly disabling orofacial pain disorder, often referred to as the "suicide disease," for which presently available therapies are largely ineffect...
Eligibility Criteria
Inclusion
- Healthy subjects who have been diagnosed with trigeminal neuralgia (TN) pain (ASA status 1, 2, or 3).
- Subjects diagnosed with TN pain must have average pain in the moderate to severe (Visual Analog Scale (VAS) of 30-100 mm) range. These subjects will be asked to stop their current medications for 24 hours prior to their scan.
- Patients diagnosed with classical trigeminal neuralgia, type 1 \[TN1, G50.00\], or symptomatic trigeminal neuralgia \[TN2, G53.80\] according to the International Classification of Headache (IHS) Disorders criteria (7).
Exclusion
- Patients diagnosed with post-herpetic neuralgia, trigeminal neuropathic pain, and trigeminal deafferentation pain.
- TN subjects with ASA status 4-5 and Emergency operation.
- Presence of chronic disease (e.g. cardiovascular disease, liver disease, kidney disease, diabetes, etc.), other than trigeminal neuralgia.
- Pregnant females
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03778177
Start Date
February 1 2019
End Date
May 12 2022
Last Update
October 6 2022
Active Locations (2)
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1
UF Health Shands Hospital
Gainesville, Florida, United States, 32610
2
McKnight Brain Institute
Gainesville, Florida, United States, 32611