Nerve Field Stimulation for Trigeminal Neuralgia

(FreeST Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Mojgan Hodaie, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a treatment where small electrical devices are placed under the skin near facial nerves to reduce pain. It targets patients with facial pain who have already had surgery. The device sends tiny electrical pulses to block pain signals.

Research Team

Mojgan Hodaie, MD, MSc

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for individuals with severe facial pain due to Trigeminal Neuralgia, who've had successful nerve stimulation surgery and can consent to study procedures. It's open to those on certain pain medications but not for pregnant women, people in other drug/device trials, or those with conditions affecting pain perception.

Inclusion Criteria

I may or may not be taking pain medication currently.

I recently had a successful nerve stimulation trial and surgery.

Capable of providing informed consent and complying with study procedures

Exclusion Criteria

Pregnant and lactating women

I have a mental health condition that affects how I feel pain.

I have had a revision surgery for a PNFS system but no other types of trigeminal pain surgery.

Treatment Details

Interventions

• Paresthesia-free Peripheral Nerve Field Stimulation (Procedure)
• Sham stimulation (Behavioural Intervention)

Trial Overview The FreeST Trial tests paresthesia-free nerve field stimulation against sham (fake) stimulation in a blinded setup where neither the participants nor the researchers know who receives which treatment until after the results are collected.

Participant Groups

Group I: Paresthesia-Free Stimulation Experimental Treatment 1 Intervention

Duration: 2 weeks

Group II: Sham Stimulation Placebo Group 1 Intervention

Duration: 2 weeks

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto