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

NCT05615714 | Recruiting Phase 1

• 1 other identifier: 21-6219
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

Peripheral Nerve Field Stimulation

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) Score Change

  VAS score change between sham condition (postop week 2-4 or postop week 4-6) and Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.

  Postoperative week 2 to week 6

Secondary Outcomes (10)

• Visual Analogue Scale (VAS) Score Change

  Postoperative week 0 to week 6

• Barrow Neurological Institute (BNI) pain intensity score change

  Postoperative week 0 to week 6

• Brief Pain Inventory (BPI) score change

  Postoperative week 0 to week 6

• Clinician and Patient Global Impression of Change Scale and Patient satisfaction scale score change

  Postoperative week 0 to week 6

• Adverse effect Profile

  Postoperative week 0 to month 12

Study Arms (2)

Paresthesia-Free Stimulation

EXPERIMENTAL

Duration: 2 weeks

Other: Paresthesia-free Peripheral Nerve Field Stimulation

Sham Stimulation

SHAM COMPARATOR

Duration: 2 weeks

Other: Sham stimulation

Interventions

Paresthesia-free Peripheral Nerve Field Stimulation OTHER

High frequency and sub-paresthesia threshold intensity parameters will be used for paresthesia-free stimulation of trigeminal nerve branches.

Paresthesia-Free Stimulation

Sham stimulation OTHER

Stimulation will be turned off.

Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Pregnant and lactating women

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia; Facial Pain

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mojgan Hodaie, MD, MSc

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Kim

CONTACT

+14166035800; jacob.kim@uhn.ca

Can Sarica, MD

CONTACT

+14377772269; can.sarica@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 14, 2022
• Study Start: October 28, 2022
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CA (2)