NCT06174818

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

September 7, 2023

Last Update Submit

December 14, 2023

Conditions

Trigeminal Neuralgia (TN)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Duration of GPE <50%

    From six weeks post procedure until definitive or possible relapse of neuralgia, assessed up to 48 months.

Study Arms (1)

TN

Patients with trigeminal neuralgia

Procedure: PRF

Interventions

PRFPROCEDURE

Pulsed Radiofrequency Current of the Gasserian Ganglion

TN

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZOL Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator (MD PhD)

Study Record Dates

First Submitted

September 7, 2023

First Posted

December 18, 2023

Study Start

April 17, 2022

Primary Completion

June 23, 2022

Study Completion

June 23, 2022

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

BE(1)