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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Nov 7, 2022

Keywords

ClinConnect Summary

The FreeST Trial is a clinical study aimed at understanding a new way to relieve facial pain caused by trigeminal neuralgia, a condition that can cause severe and sudden facial pain. This trial will look at a treatment called peripheral nerve field stimulation (PNFS) that doesn’t cause tingling sensations, which is often a side effect of similar treatments. Participants in this study will have already had a successful trial of this treatment and then permanent surgery to implant the device. They will be monitored for a year to find out how well the treatment helps with their pain.

To be eligible for the trial, participants should be between the ages of 65 and 74 and have a specific type of facial pain that hasn't responded well to other treatments. They must also be able to give their consent and follow the study procedures. During the trial, participants will go through different phases, including a period where they might receive either real or sham (fake) stimulation without knowing which one they are getting. This helps ensure the results are reliable. Overall, the study aims to find out which treatment settings work best for reducing pain and improving comfort for people suffering from this challenging condition.

Gender

ALL

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