Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial) (FreeST)

February 22, 2024 updated by: Mojgan Hodaie, University Health Network, Toronto

Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia: a Double-blinded, Randomized Trial (FreeST Trial)

Study type: Prospective, double-blinded, double arm, cross-over, randomized controlled clinical trial.

Brief protocol:

Postoperative week 0-2 -> Conventional parameters (parameters tested during trial period)

Postoperative week 2-6 -> Sham stimulation (2 weeks) and paresthesia-free stimulation (2 weeks) double-blind crossover design

Postoperative week 6 - month 12 -> Parameters that patients feel more benefit from

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Peripheral Nerve Field Stimulation (PNFS) has been utilized for the treatment of facial pain for around 60 years, and the commercial devices needed to deliver PNFS have been available for around 30 years. The safety and efficacy of the procedure has been demonstrated by various uncontrolled observational studies. It serves as a part of daily neurosurgical practice for selected patients in UHN Toronto Western Hospital. This therapeutic modality involves subcutaneous implantation of electrodes in the vicinity of trigeminal nerve branches and application of electrical current using a permanently implanted pulse generator (IPG). Similar to other forms of neuromodulation, PNFS is non-ablative, reversible, adjustable and associated with a relatively low risk of severe complications. A meta-analysis of paresthesia-inducing (PI) PFNS studies in the literature revealed a treatment efficacy of 75% decrease in VAS scores (mean difference: -6.32 out of 10) with PNFS utilization for facial pain. (PMID: 35180702)

Study design:

Patients who underwent a successful unilateral PNFS implantation surgery (trial and permanent implantation) for a facial pain syndrome as a standard of care treatment, will be screened for inclusion after permanent implantable pulse generator (IPG) implantation. Upon consent, the investigators will set up participants' IPG to deliver stimulation with parameters tested during the trial period (paresthesia-inducing parameters) for 2 weeks. The participants will come back to hospital at postoperative week 2 and will be randomized (1:1 ratio) between the two arms of the study (Group 1= sham, Group 2= paresthesia-free (PF) stimulation). Each participant will consecutively experience all two stimulation groups by 2-week periods in a crossover design. Both participants and clinical investigators that will assess the pain will be blind during the study period (between postoperative week 2 and 6). After 6 weeks, the treatment arms will be merged and all the participants will receive any stimulation parameter that they feel more benefit from ("best" parameter). Outcomes will be assessed 6 and 12 months post-operatively.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 1

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 Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital, University Health Network
        • Contact:
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
        • Principal Investigator:
          • Christian Iorio-Morin, MD, 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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of a medically-refractory unilateral facial pain syndrome as defined by the Burchiel classification but excluding atypical facial pain (somatoform pain disorder)
  • Recent successful PNFS trial and permanent implantation surgery
  • Average preoperative episodic/constant pain intensity of 5 or greater out of 10 cm on the VAS
  • Capable of providing informed consent and complying with study procedures
  • Patients may or may not use a pain medication at the time of recruitment. Medications allowed during the study are long-acting/modulatory analgesics (anticonvulsants such as carbamezapine, oxcarbazepine, pregabalin, gabapentin, lamotrigine; baclofen, botox injections) and short-acting analgesics (non-steroid anti-inflammatory drugs, short-acting opioids, lidocaine or sumatriptan injections)

Exclusion Criteria:

  • Currently in a clinical trial involving an investigational product or non-approved use of a drug or device.
  • Active psychiatric disorder or other known condition that can significantly impact pain perception
  • Patients with a revision surgery of a PNFS system by any reason (history of trigeminal pain surgery of other types (i.e., microvascular decompression, gamma knife, percutaneous rhizotomies) are not exclusion criteria)
  • Pregnant and lactating women

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paresthesia-Free Stimulation
Duration: 2 weeks
Other: Paresthesia-free Peripheral Nerve Field Stimulation
High frequency and sub-paresthesia threshold intensity parameters will be used for paresthesia-free stimulation of trigeminal nerve branches.
Sham Comparator: Sham Stimulation
Duration: 2 weeks
Other: Sham stimulation
Stimulation will be turned off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Score Change
Time Frame: Postoperative week 2 to week 6
VAS score change between sham condition (postop week 2-4 or postop week 4-6) and Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.
Postoperative week 2 to week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Score Change
Time Frame: Postoperative week 0 to week 6
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.
Postoperative week 0 to week 6
Barrow Neurological Institute (BNI) pain intensity score change
Time Frame: Postoperative week 0 to week 6
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison BNI score ranges from 1 to 5. Higher score is worse outcome.
Postoperative week 0 to week 6
Brief Pain Inventory (BPI) score change
Time Frame: Postoperative week 0 to week 6
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison BPI-Pain Severity Score and BPI-Pain Interference Score range from 0 to 10. Higher score is worse outcome.
Postoperative week 0 to week 6
Clinician and Patient Global Impression of Change Scale and Patient satisfaction scale score change
Time Frame: Postoperative week 0 to week 6
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison Clinician and Patient Global Impression of Change Scale (range from 1 to 7) and Patient satisfaction scale (range from 1 to 5). Higher score is worse outcome.
Postoperative week 0 to week 6
Adverse effect Profile
Time Frame: Postoperative week 0 to month 12
Adverse effect Profile
Postoperative week 0 to month 12
Ratio of patients who chose paresthesia-free or paresthesia-inducing stimulation at week 6, month 6 and 12
Time Frame: Postoperative week 6, month 6 and 12
paresthesia-free or paresthesia-inducing stimulation
Postoperative week 6, month 6 and 12
fMRI BOLD signal change
Time Frame: Between postoperative month 6 and 12
IPG ON>OFF BOLD signal change (both paresthesia-free and Paresthesia-inducing conditions will be tested)
Between postoperative month 6 and 12
Visual Analogue Scale (VAS) Score Change
Time Frame: Postoperative month 6 and 12
Score changes between baseline and postoperative 6 and 12 months VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.
Postoperative month 6 and 12
Barrow Neurological Institute (BNI) pain intensity score change
Time Frame: Postoperative month 6 and 12
Score changes between baseline and postoperative 6 and 12 months BNI score ranges from 1 to 5. Higher score is worse outcome.
Postoperative month 6 and 12
Brief Pain Inventory (BPI) score change
Time Frame: Postoperative month 6 and 12
Score changes between baseline and postoperative 6 and 12 months BPI-Pain Severity Score and BPI-Pain Interference Score range from 0 to 10. Higher score is worse outcome.
Postoperative month 6 and 12

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Mojgan Hodaie, MD, MSc, University of Toronto

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)

October 28, 2022

Primary Completion (Estimated)

October 28, 2024

Study Completion (Estimated)

October 28, 2024

Study Registration Dates

First Submitted

October 30, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-6219

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Facial Pain

Clinical Trials on Paresthesia-free Peripheral Nerve Field Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe