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

NCT ID: NCT05615714

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2024-10-28

Brief Summary

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

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.

Conditions

Trigeminal Neuralgia; Facial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Paresthesia-Free Stimulation

Duration: 2 weeks

Group Type: EXPERIMENTAL

Paresthesia-free Peripheral Nerve Field Stimulation

Intervention Type: OTHER

High frequency and sub-paresthesia threshold intensity parameters will be used for paresthesia-free stimulation of trigeminal nerve branches.

Sham Stimulation

Duration: 2 weeks

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: OTHER

Stimulation will be turned off.

Interventions

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.

Intervention Type: OTHER

Sham stimulation

Stimulation will be turned off.

Intervention Type: OTHER

Eligibility Criteria

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
• Pregnant and lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Mojgan Hodaie

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mojgan Hodaie, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jacob Kim

Role: CONTACT

jacob.kim@uhn.ca

+14166035800

Can Sarica, MD

Role: CONTACT

can.sarica@uhn.ca

+14377772269

Facility Contacts

Jakob Kim

Role: primary

jacob.kim@uhn.ca

+14166035800

Andréanne Hamel

Role: primary

andreanne.hamel@usherbrooke.ca

(819) 346-1110 ext. 16365

Other Identifiers

21-6219

Identifier Type: -

Identifier Source: org_study_id