Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study

Trigeminal Neuralgia (TN) Clinical Trial

— Progress  

Official title:

Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06174818
• Other study ID #: Z-2021102
• Status: Completed
• Start date: April 17, 2022
• Est. completion date: June 23, 2022

Study information

• Verified date: December 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the Pulsed Radiofrequency treatment (PRF) Of the Gasserian ganglion for tRigeminal nEuralgia: a retroSpective Study (PROGRESS) the objective is to document the outcome of PRF (Pulsed Radiofrequency treatment) for patients with TN (Trigeminal Neuralgia), unresponsive to conservative treatment.

Description:

Primary objective: To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE (Global perceived effect) score (six weeks after treatment) Secondary objectives: - To determine the duration during which PRF of the Gasserian ganglion for trigeminal neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with trigeminal neuralgia who underwent their first PRF of the Gasserian ganglion between 01/09/2013 and 31/08/2021

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia
• Trigeminal Neuralgia (TN)

Intervention

Procedure:
• PRF
Pulsed Radiofrequency Current of the Gasserian Ganglion

Locations

Country	Name	City	State
Belgium	ZOL Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GPE <50%	To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE (Global perceived effect) score (six weeks after treatment)	Six weeks after treatment
Secondary	Duration of GPE <50%	To determine the duration during which PRF of the Gasserian ganglion for trigeminal neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score. This will be assessed six weeks post procedure and will be followed-up until definitive or possible relapse of neuralgia, assessed up to 48 months.	From six weeks post procedure until definitive or possible relapse of neuralgia, assessed up to 48 months.