What side effects are associated with this type of intervention?

Common treatments for Trigeminal Neuralgia using neuromodulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), generally have mild side effects. These can include sensations like warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. Serious adverse events are rare. For TMS specifically, there is a theoretical risk of triggering seizures, particularly in patients with epilepsy. Overall, these treatments are considered safe with a low incidence of severe side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Trigeminal Neuralgia, including medications like carbamazepine and oxcarbazepine, which are anticonvulsants. For neuromodulation, the FDA has approved spinal cord stimulation and peripheral nerve stimulation, which typically involve paresthesia (a tingling sensation). The Paresthesia-Free Stimulation being studied in the FreeST Trial represents a novel approach, aiming to provide pain relief without the tingling sensation associated with traditional neuromodulation therapies.

What other types of research exist?

Promising novel alternatives to Paresthesia-Free Stimulation for Trigeminal Neuralgia include: 1) High-frequency Spinal Cord Stimulation (SCS), which has shown efficacy in various neuropathic pain conditions. 2) Repetitive Transcranial Magnetic Stimulation (rTMS), which has demonstrated potential in reducing pain severity in small clinical trials. 3) Scrambler Therapy, which has been effective in relieving chronic neuropathic pain in pilot studies. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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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

Recent successful PNFS trial and permanent implantation surgery

Diagnosis of a medically-refractory unilateral facial pain syndrome as defined by the Burchiel classification but excluding atypical facial pain (somatoform pain disorder)

Must not have

Active psychiatric disorder or other known condition that can significantly impact pain perception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative week 6, month 6 and 12

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I recently had a successful nerve stimulation trial and surgery.

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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.

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My average pain level before surgery was 5 or more out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative week 6, month 6 and 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Adverse effect Profile

Pain

Brief Pain Inventory (BPI) score change

+4 more

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Trigeminal Neuralgia (TN) is often treated with medications like carbamazepine, which stabilizes nerve membranes and reduces pain by inhibiting sodium channels. Neuromodulation techniques, such as Paresthesia-Free Stimulation, aim to alleviate pain by altering nerve activity without causing the tingling sensation (paresthesia) typically associated with traditional nerve stimulation. This is achieved through specific electrical parameters that modulate pain pathways. Understanding these mechanisms is crucial for TN patients as it helps in selecting treatments that provide effective pain relief while minimizing side effects, thereby improving their quality of life.

Stereotactic radiosurgery of essential trigeminal neuralgia using Leksell Gamma Knife model C with automatic positioning system: technical nuances and evaluation of outcome in 130 patients with at least 2 years follow-up after treatment.