Recruiting
Phase 1
Phase 2

Peripheral Nerve Stimulation

Sponsor:

University Health Network, Toronto

Code:

NCT05615714

Conditions

Trigeminal Neuralgia

Facial Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paresthesia-free Peripheral Nerve Field Stimulation

Sham stimulation

Study Details

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

Conditions

Trigeminal Neuralgia

Facial Pain

Study ID

NCT05615714

Start date

Oct 28, 2022

Status verified date

Feb, 2024

Completion date

Oct 28, 2024

Anticipated

Primary completion date

Oct 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Paresthesia-Free Stimulation

Duration: 2 weeks

sham comparator: Sham Stimulation

Duration: 2 weeks

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.

Sham stimulation

Stimulation will be turned off.

Primary outcome measure

  • Visual Analogue Scale (VAS) Score Change [ Time Frame: Postoperative week 2 to week 6 ]

Central Contacts and Locations

Central contacts

Jacob Kim

+14166035800jacob.kim@uhn.ca

Can Sarica, MD

+14377772269can.sarica@uhn.ca

Locations

Toronto Western Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Jakob Kim

+14166035800jacob.kim@uhn.ca

Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Andréanne Hamel

(819) 346-1110andreanne.hamel@usherbrooke.ca

Principal Investigator:

Christian Iorio-Morin, MD, PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Keywords

  • Peripheral Nerve Field Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-02-23.