Paresthesia-free stimulation for trigeminal neuralgia

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

This study is testing a new way to relieve facial pain for people with trigeminal neuralgia using a special stimulation technique that doesn't cause tingling sensations.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 2 sites (Toronto, Ontario and 1 other locations)
• Trial ID: NCT05615714 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of paresthesia-free Peripheral Nerve Field Stimulation (PNFS) for patients suffering from trigeminal neuralgia and facial pain. It is a prospective, double-blinded, randomized controlled trial that involves a crossover design, where participants will receive both active and sham stimulation at different intervals. The study aims to assess pain relief and patient-reported outcomes over a 12-month period following the implantation of a pulse generator. The trial builds on previous findings that indicate PNFS can significantly reduce pain levels in patients with facial pain syndromes.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with medically-refractory unilateral facial pain syndromes who have recently undergone successful PNFS implantation.

Not a fit: Patients with atypical facial pain or those currently participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with trigeminal neuralgia, potentially reducing their pain without the side effects associated with traditional stimulation methods.

How similar studies have performed: Previous studies have shown promising results with PNFS for facial pain, indicating that this approach is based on established methods but aims to refine the technique to enhance patient comfort and outcomes.

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
* 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

Where this trial is running

Toronto, Ontario and 1 other locations

• Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
• Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Mojgan Hodaie, MD, MSc — University of Toronto
• Study coordinator: Jacob Kim

Conditions Trigeminal Neuralgia; Facial Pain; Peripheral Nerve Field Stimulation