FMRI Assessment After Radiofrequency in Trigeminal Neuralgia

Assiut University

Status: Unknown

Conditions: Trigeminal Neuralgia; Pain, Neuropathic

Treatments: Procedure: thermal Radiofrequency; Procedure: pulsed Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT03305289

RF in trigeminal neuralgia

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

pulsed radiofrequency

Active Comparator group

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

Treatment:

Procedure: pulsed Radiofrequency

thermal Radiofrequency

Active Comparator group

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

Treatment:

Procedure: thermal Radiofrequency