FMRI Assessment After Radiofrequency in Trigeminal Neuralgia

Not Applicable

• Conditions: Pain, Neuropathic; Trigeminal Neuralgia
• Interventions: Procedure: pulsed Radiofrequency; Procedure: thermal Radiofrequency

• Registration Number: NCT03305289
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-25
• Last Update Posted: 2020-07-28
• Study Start: 2020-12-01
• Primary Completion: 2021-10-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 20 - 65 years
• Primary trigeminal neuralgia
• Maxillary and/or mandibular affection only
• Failure of medical treatment

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Exclusion Criteria

• 2ry trigeminal neuralgia
• Recurrent trigeminal neuralgia
• Ophthalmic branch affection
• Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,...)
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulsed radiofrequency	pulsed Radiofrequency	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
thermal Radiofrequency	thermal Radiofrequency	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 Measures

Name	Time	Method
pain alleviation	1 month	pain assessment by functional MRI