FMRI Assessment After Radiofrequency in Trigeminal Neuralgia
Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
October 9, 2017
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedJuly 28, 2020
July 1, 2020
11 months
September 22, 2017
July 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
pain alleviation
pain assessment by functional MRI
1 month
Study Arms (2)
pulsed radiofrequency
ACTIVE COMPARATORsensory 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
thermal Radiofrequency
ACTIVE COMPARATORsensory 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Age 20 - 65 years
- Primary trigeminal neuralgia
- Maxillary and/or mandibular affection only
- Failure of medical treatment
You may not qualify if:
- ry trigeminal neuralgia
- Recurrent trigeminal neuralgia
- Ophthalmic branch affection
- Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,…)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisstant lecture
Study Record Dates
First Submitted
September 22, 2017
First Posted
October 9, 2017
Study Start
December 1, 2020
Primary Completion
October 30, 2021
Study Completion
October 30, 2022
Last Updated
July 28, 2020
Record last verified: 2020-07