NCT06779578

Brief Summary

A prospective exploratory study aiming at comparing pulsed bipolar versus pulsed unipolar radiofrequency ablation in patients with medically refractory trigeminal neuralgia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

January 13, 2025

Last Update Submit

January 16, 2025

Conditions

Trigeminal NeuralgiaRefractory Pain

Keywords

trigeminal neuralgiaRadiofrequency ablationPulsed radiofrequencyMonopolar pulsed radiofrequencyBipolar pulsed radiofrequnency

Outcome Measures

Primary Outcomes (1)

  • Numerical pain scale (NRS)

    50% Pain reduction in the numerical rating scale (NRS)

    Two weeks, 1 month, 3 months, and 6 months

Secondary Outcomes (1)

  • Adverse events monitoring (Frequency, severity, seriousness, and causality)

    6 months

Study Arms (2)

Monopolar pulsed radiofrequncy

PLACEBO COMPARATOR

Patients with refractory TN undergoing monopolar pulsed radiofrequency

Procedure: Mopolar pulsed radiofrequency

Bipolar pulsed radiofrequency

ACTIVE COMPARATOR

Patients with refractory TN undergoing bipolar pulsed radiofrequency

Procedure: Bipolar pulsed radiofrequency

Interventions

Bipolar pulsed radiofrequencyPROCEDURE

Bipolar pulsed radiofrequency ablation: the active comparator

Bipolar pulsed radiofrequency
Mopolar pulsed radiofrequencyPROCEDURE

Monopolar pulsed radiofrequency ablation: the placebo

Monopolar pulsed radiofrequncy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a definitive diagnosis of classical TN based on the third version of the International Classification of Headache Disorders (ICHD-3).
  • Either purely paroxysmal classical TN or classical TN with concomitant chronic pain.
  • Patients with idiopathic TN, with symptomatic clinical topography of V2 and/or V3.
  • Patients with brain magnetic resonance imaging (MRI) unremarkable for structural etiology for the trigeminal pain.
  • Patients with medically refractory TN defined as pain persisting beyond three months at a level of ≥5/10 after monotherapy or polytherapy in appropriate medical doses.

You may not qualify if:

  • Painful trigeminal neuropathy based on the third version of the International Classification of Headache Disorders (ICHD-3).
  • Trigeminal neuralgia with V1 symptomatic clinical topography.
  • Trigeminal neuralgia comorbid with other atypical facial pain disorders.
  • Structural TN e.g., due to vascular compression, posterior fossa tumors, central demyelination, …etc.
  • Patients exposed to previous radiofrequency procedures, as this may impair the nerve response to current PRF.
  • Patients who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexandria University Faculty of Medicine

Alexandria, 21517, Egypt

RECRUITING

Cairo University Kasr Alainy Faculty of Medicine

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Trigeminal NeuralgiaPain, Intractable

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eman Hamdy, PhD

CONTACT

+201061402092eman.ameen@alexmed.edu.eg

Ahmed Elshal, PhD

CONTACT

+201002998841dr.ahmedelshal@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Explaratory
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Neurology

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 16, 2025

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

January 17, 2025

Record last verified: 2025-01

Locations

EG(2)