Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial) (FreeST)
Trigeminal Neuralgia, Facial Pain
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Peripheral Nerve Field Stimulation
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
Sites / Locations
- Toronto Western Hospital, University Health NetworkRecruiting
- Centre hospitalier universitaire de SherbrookeRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Paresthesia-Free Stimulation
Sham Stimulation
Duration: 2 weeks
Duration: 2 weeks