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

NCT05615714 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-23

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

Sham stimulation

Stimulation will be turned off.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Mojgan Hodaie, MD, MSc · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2024-10-28
Completion
2024-10-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615714 on ClinicalTrials.gov