Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia

January 16, 2025 updated by: Eman Hamdy, Alexandria University

The Efficacy and Safety of Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia: An Exploratory Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a prospective exploratory that will be conducted on patients with the inclusion and exclusion criteria detailed.

At the baseline visit, the sociodemographic data (age, sex, smoking status) and clinical data (TN etiology (idiopathic or symptomatic), TN phenotype (purely paroxysmal or with concomitant continuous pain), clinical symptoms topography (V2, V3), brain MRI findings, previous medications and interventions, and comorbidities) will be collected. The patients will be randomly assigned to undergo bipolar PRF or monopolar PRF using a simple randomization technique.

Pain scores will be assessed using the nominal rating scale (NRS) at baseline, within two weeks postoperatively, and at 1-month, 3-month, and 6-month intervals. Patient satisfaction will be assessed within two weeks following the intervention on a five-point Likert scale (5 represents very good and 1 means very bad). Treatment success will be defined as at least a 50% reduction in pain scores. The duration to pain control and the duration to pain recurrence/rebound will be assessed at follow-up visits. The patient's postoperative need for medications or further pain interventions will be detailed. Intraoperative and postinterventional complications will be monitored and documented.

Study interventions For the PRF procedure, all patients will be prepared in the operating room and will undergo standard operative monitoring (i.e., blood pressure, electrocardiography, and pulse oximetry). They will be positioned in a supine position with slight neck extension. Sedation will be provided (100 Ig fentanyl and 2 mg midazolam intravenously). Skin preparation will be performed using chlorhexidine.

I- Monopolar PRF In the monopolar PRF, an RF cannula (22-gauge, 100 mm, with a 10 mm active tip (SMK)) will be percutaneously advanced at the posterior border of the foramen ovale under fluoroscopic guidance. For confirming the detection of the mandibular nerve, sensory stimulation will be performed via the radiofrequency generator at a current of 0.5 to 1 V at a frequency of 50 Hz to elicit paresthesia response in the mandibular region. Motor stimulation will be performed via the generator at a current of 1 - 2 V applied at a frequency of 2 Hz to obtain a contraction response at the masseter muscle. After obtaining the appropriate responses, PRF will be applied at a fixed heat energy of 42 °C for a period of 240 seconds10.

II- Bipolar PRF For bipolar PRF, two RF cannulas will be advanced in the foramen ovale under fluoroscopic guidance. The first (22-gauge, 100 mm, and 10-mm active tip (SMK)) will be placed at the anterior border of the foramen ovale, and then the second (same parameters) will be advanced at the posterior border. The correct position will be confirmed on the lateral position until the correct placement at V2. Sensory and motor testing will be performed as aforementioned in the monopolar PRF to confirm the appropriate capture of the trigeminal nerve. Following obtaining the appropriate responses, PRF will be performed in two cycles, three minutes each, at a temperature of 42ºC and a current of 85 V and a 20-millisecond pulse width13.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Alexandria, Egypt, 21517
        • Recruiting
        • ALEXANDRIA UNIVERSITY FACULTY OF MEDICINE
        • Contact:
          • Eman Hamdy, PhD
      • Cairo, Egypt
        • Recruiting
        • Cairo University Kasr Alainy Faculty of Medicine
        • Contact:
          • Ahmed Elshal, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with a definitive diagnosis of classical TN based on the third version of the International Classification of Headache Disorders (ICHD-3).
  2. Either purely paroxysmal classical TN or classical TN with concomitant chronic pain.
  3. Patients with idiopathic TN, with symptomatic clinical topography of V2 and/or V3.
  4. Patients with brain magnetic resonance imaging (MRI) unremarkable for structural etiology for the trigeminal pain.
  5. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Monopolar pulsed radiofrequncy
Patients with refractory TN undergoing monopolar pulsed radiofrequency
Procedure: Mopolar pulsed radiofrequency
Monopolar pulsed radiofrequency ablation: the placebo
Active Comparator: Bipolar pulsed radiofrequency
Patients with refractory TN undergoing bipolar pulsed radiofrequency
Procedure: Bipolar pulsed radiofrequency
Bipolar pulsed radiofrequency ablation: the active comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numerical pain scale (NRS)
Time Frame: Two weeks, 1 month, 3 months, and 6 months
50% Pain reduction in the numerical rating scale (NRS)
Two weeks, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events monitoring (Frequency, severity, seriousness, and causality)
Time Frame: 6 months
Frequency, type, and severity of adverse events. Classification of AEs as mild, moderate, or severe. Assessment of causality between the treatment and the AE
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0307084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings