FMRI Assessment After Radiofrequency in Trigeminal Neuralgia

NCT ID: NCT03305289

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-10-30

Brief Summary

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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

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Conditions

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Trigeminal Neuralgia Pain, Neuropathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

pulsed Radiofrequency

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

thermal Radiofrequency

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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mohamed elsayed

assisstant lecture

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RF in trigeminal neuralgia

Identifier Type: -

Identifier Source: org_study_id

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