FMRI Assessment After Radiofrequency in Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03305289
• Other study ID #: RF in trigeminal neuralgia
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Pain, Neuropathic
• Trigeminal Neuralgia

Intervention

Procedure:
• 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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain alleviation	pain assessment by functional MRI	1 month