Back to resultsFMRI Assessment After Radiofrequency in Trigeminal Neuralgia
Primary Purpose
Trigeminal Neuralgia, Pain, Neuropathic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulsed Radiofrequency
thermal Radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia
Eligibility Criteria
Inclusion Criteria:
- Age 20 - 65 years
- Primary trigeminal neuralgia
- Maxillary and/or mandibular affection only
- Failure of medical treatment
Exclusion Criteria:
- 2ry trigeminal neuralgia
- Recurrent trigeminal neuralgia
- Ophthalmic branch affection
- Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,…)
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
pulsed radiofrequency
thermal Radiofrequency
Arm Description
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds
Outcomes
Primary Outcome Measures
pain alleviation
pain assessment by functional MRI
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03305289
Brief Title
FMRI Assessment After Radiofrequency in Trigeminal Neuralgia
Official Title
Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the brain activations related to TN, using fMRI, and to evaluate changes in these activations following the application of pulsed and thermal Radiofrequency lesioning to the gasserien ganglion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia, Pain, Neuropathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pulsed radiofrequency
Arm Type
Active Comparator
Arm Description
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins
Arm Title
thermal Radiofrequency
Arm Type
Active Comparator
Arm Description
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds
Intervention Type
Procedure
Intervention Name(s)
pulsed Radiofrequency
Intervention Description
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins
Intervention Type
Procedure
Intervention Name(s)
thermal Radiofrequency
Intervention Description
sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds
Primary Outcome Measure Information:
Title
pain alleviation
Description
pain assessment by functional MRI
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 20 - 65 years
Primary trigeminal neuralgia
Maxillary and/or mandibular affection only
Failure of medical treatment
Exclusion Criteria:
2ry trigeminal neuralgia
Recurrent trigeminal neuralgia
Ophthalmic branch affection
Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,…)
Pregnancy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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FMRI Assessment After Radiofrequency in Trigeminal Neuralgia
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