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

NCT ID: NCT06174818

Last Updated: 2023-12-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-17

Study Completion Date

2022-06-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trigeminal Neuralgia (TN)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TN

Patients with trigeminal neuralgia

PRF

Intervention Type PROCEDURE

Pulsed Radiofrequency Current of the Gasserian Ganglion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRF

Pulsed Radiofrequency Current of the Gasserian Ganglion

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Koen Van Boxem

principal investigator (MD PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ZOL Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Z-2021102

Identifier Type: -

Identifier Source: org_study_id