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Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial)

Phase 1 & 2
Recruiting
Led By Mojgan Hodaie, MD, MSc
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Average preoperative episodic/constant pain intensity of 5 or greater out of 10 cm on the VAS
Diagnosis of a medically-refractory unilateral facial pain syndrome as defined by the Burchiel classification but excluding atypical facial pain (somatoform pain disorder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative week 6, month 6 and 12
Awards & highlights

FreeST Trial Summary

This trial tests two ways to manage post-op pain in a randomized, double-blinded design to compare their effects.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed, similar nerve stimulation treatments may cause discomfort at the implant site, changes in skin sensation, headaches or dizziness. The exact side effects will be monitored throughout the trial.

FreeST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My average pain level before surgery is 5 or more on a scale of 10.
Select...
I have been diagnosed with a severe type of facial pain that doesn't respond to treatment, but it's not due to a psychological condition.
Select...
I recently had a successful nerve stimulation trial and surgery.
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I may or may not be taking pain medication currently.
Select...
I recently had a successful nerve stimulation trial and surgery.
Select...
I have been diagnosed with a severe type of facial pain that doesn't respond to treatment, but it's not due to a psychological condition.
Select...
My average pain level before surgery was 5 or more out of 10.

FreeST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative week 6, month 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative week 6, month 6 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Adverse effect Profile
Pain
Brief Pain Inventory (BPI) score change
+4 more

FreeST Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Paresthesia-Free StimulationExperimental Treatment1 Intervention
Duration: 2 weeks
Group II: Sham StimulationPlacebo Group1 Intervention
Duration: 2 weeks

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,464 Previous Clinical Trials
483,577 Total Patients Enrolled
1 Trials studying Trigeminal Neuralgia
1 Patients Enrolled for Trigeminal Neuralgia
Mojgan Hodaie, MD, MScPrincipal InvestigatorUniversity of Toronto

Media Library

Paresthesia-free Peripheral Nerve Field Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT05615714 — Phase 1 & 2
Trigeminal Neuralgia Research Study Groups: Paresthesia-Free Stimulation, Sham Stimulation
Trigeminal Neuralgia Clinical Trial 2023: Paresthesia-free Peripheral Nerve Field Stimulation Highlights & Side Effects. Trial Name: NCT05615714 — Phase 1 & 2
Paresthesia-free Peripheral Nerve Field Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05615714 — Phase 1 & 2
Trigeminal Neuralgia Patient Testimony for trial: Trial Name: NCT05615714 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has this clinical trial attracted participants?

"Affirmative. Clinicaltrials.gov has verified that this medical research project, which was first published on October 28th 2022, is still actively enrolling participants. The trial requires 24 individuals to be recruited from a single center."

Answered by AI

Is the recruitment of participants ongoing for this trial?

"According to clinicaltrials.gov, this research is currently recruiting patients; the study was first listed on October 28th 2022 and recently updated a few days ago in November 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have sensory allodynia to current pns. Abbott burst and tonic and unsatisfactory pain control.
PatientReceived 1 prior treatment
~6 spots leftby Oct 2024