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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation 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