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

Primary Purpose

Trigeminal Neuralgia, Facial Pain

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Paresthesia-free Peripheral Nerve Field Stimulation
Sham stimulation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Peripheral Nerve Field Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 Patients with a revision surgery of a PNFS system by any reason (history of trigeminal pain surgery of other types (i.e., microvascular decompression, gamma knife, percutaneous rhizotomies) are not exclusion criteria) Pregnant and lactating women

Sites / Locations

  • Toronto Western Hospital, University Health NetworkRecruiting
  • Centre hospitalier universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Paresthesia-Free Stimulation

Sham Stimulation

Arm Description

Duration: 2 weeks

Duration: 2 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analogue Scale (VAS) Score Change
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.
Barrow Neurological Institute (BNI) pain intensity score change
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison BNI score ranges from 1 to 5. Higher score is worse outcome.
Brief Pain Inventory (BPI) score change
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison BPI-Pain Severity Score and BPI-Pain Interference Score range from 0 to 10. Higher score is worse outcome.
Clinician and Patient Global Impression of Change Scale and Patient satisfaction scale score change
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison Clinician and Patient Global Impression of Change Scale (range from 1 to 7) and Patient satisfaction scale (range from 1 to 5). Higher score is worse outcome.
Adverse effect Profile
Adverse effect Profile
Ratio of patients who chose paresthesia-free or paresthesia-inducing stimulation at week 6, month 6 and 12
paresthesia-free or paresthesia-inducing stimulation
fMRI BOLD signal change
IPG ON>OFF BOLD signal change (both paresthesia-free and Paresthesia-inducing conditions will be tested)
Visual Analogue Scale (VAS) Score Change
Score changes between baseline and postoperative 6 and 12 months VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.
Barrow Neurological Institute (BNI) pain intensity score change
Score changes between baseline and postoperative 6 and 12 months BNI score ranges from 1 to 5. Higher score is worse outcome.
Brief Pain Inventory (BPI) score change
Score changes between baseline and postoperative 6 and 12 months BPI-Pain Severity Score and BPI-Pain Interference Score range from 0 to 10. Higher score is worse outcome.

Full Information

First Posted
October 30, 2022
Last Updated
October 4, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05615714
Brief Title
Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial)
Acronym
FreeST
Official Title
Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia: a Double-blinded, Randomized Trial (FreeST Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
October 28, 2023 (Anticipated)
Study Completion Date
October 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Background: Peripheral Nerve Field Stimulation (PNFS) has been utilized for the treatment of facial pain for around 60 years, and the commercial devices needed to deliver PNFS have been available for around 30 years. The safety and efficacy of the procedure has been demonstrated by various uncontrolled observational studies. It serves as a part of daily neurosurgical practice for selected patients in UHN Toronto Western Hospital. This therapeutic modality involves subcutaneous implantation of electrodes in the vicinity of trigeminal nerve branches and application of electrical current using a permanently implanted pulse generator (IPG). Similar to other forms of neuromodulation, PNFS is non-ablative, reversible, adjustable and associated with a relatively low risk of severe complications. A meta-analysis of paresthesia-inducing (PI) PFNS studies in the literature revealed a treatment efficacy of 75% decrease in VAS scores (mean difference: -6.32 out of 10) with PNFS utilization for facial pain. (PMID: 35180702) Study design: Patients who underwent a successful unilateral PNFS implantation surgery (trial and permanent implantation) for a facial pain syndrome as a standard of care treatment, will be screened for inclusion after permanent implantable pulse generator (IPG) implantation. Upon consent, the investigators will set up participants' IPG to deliver stimulation with parameters tested during the trial period (paresthesia-inducing parameters) for 2 weeks. The participants will come back to hospital at postoperative week 2 and will be randomized (1:1 ratio) between the two arms of the study (Group 1= sham, Group 2= paresthesia-free (PF) stimulation). Each participant will consecutively experience all two stimulation groups by 2-week periods in a crossover design. Both participants and clinical investigators that will assess the pain will be blind during the study period (between postoperative week 2 and 6). After 6 weeks, the treatment arms will be merged and all the participants will receive any stimulation parameter that they feel more benefit from ("best" parameter). Outcomes will be assessed 6 and 12 months post-operatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia, Facial Pain
Keywords
Peripheral Nerve Field Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paresthesia-Free Stimulation
Arm Type
Experimental
Arm Description
Duration: 2 weeks
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
Duration: 2 weeks
Intervention Type
Other
Intervention Name(s)
Paresthesia-free Peripheral Nerve Field Stimulation
Intervention Description
High frequency and sub-paresthesia threshold intensity parameters will be used for paresthesia-free stimulation of trigeminal nerve branches.
Intervention Type
Other
Intervention Name(s)
Sham stimulation
Intervention Description
Stimulation will be turned off.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Score Change
Description
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.
Time Frame
Postoperative week 2 to week 6
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Score Change
Description
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.
Time Frame
Postoperative week 0 to week 6
Title
Barrow Neurological Institute (BNI) pain intensity score change
Description
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison BNI score ranges from 1 to 5. Higher score is worse outcome.
Time Frame
Postoperative week 0 to week 6
Title
Brief Pain Inventory (BPI) score change
Description
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison BPI-Pain Severity Score and BPI-Pain Interference Score range from 0 to 10. Higher score is worse outcome.
Time Frame
Postoperative week 0 to week 6
Title
Clinician and Patient Global Impression of Change Scale and Patient satisfaction scale score change
Description
Score changes between sham condition (postop week 2-4 or postop week 4-6), Paresthesia-free stimulation condition (postop week 2-4 or postop week 4-6) and Paresthesia-inducing stimulation condition (postop week 0-2) Non-independent within-group comparison Clinician and Patient Global Impression of Change Scale (range from 1 to 7) and Patient satisfaction scale (range from 1 to 5). Higher score is worse outcome.
Time Frame
Postoperative week 0 to week 6
Title
Adverse effect Profile
Description
Adverse effect Profile
Time Frame
Postoperative week 0 to month 12
Title
Ratio of patients who chose paresthesia-free or paresthesia-inducing stimulation at week 6, month 6 and 12
Description
paresthesia-free or paresthesia-inducing stimulation
Time Frame
Postoperative week 6, month 6 and 12
Title
fMRI BOLD signal change
Description
IPG ON>OFF BOLD signal change (both paresthesia-free and Paresthesia-inducing conditions will be tested)
Time Frame
Between postoperative month 6 and 12
Title
Visual Analogue Scale (VAS) Score Change
Description
Score changes between baseline and postoperative 6 and 12 months VAS score ranges from 0 to 100 mm (or 0 to 10 cm). Higher score is worse outcome.
Time Frame
Postoperative month 6 and 12
Title
Barrow Neurological Institute (BNI) pain intensity score change
Description
Score changes between baseline and postoperative 6 and 12 months BNI score ranges from 1 to 5. Higher score is worse outcome.
Time Frame
Postoperative month 6 and 12
Title
Brief Pain Inventory (BPI) score change
Description
Score changes between baseline and postoperative 6 and 12 months BPI-Pain Severity Score and BPI-Pain Interference Score range from 0 to 10. Higher score is worse outcome.
Time Frame
Postoperative month 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Patients with a revision surgery of a PNFS system by any reason (history of trigeminal pain surgery of other types (i.e., microvascular decompression, gamma knife, percutaneous rhizotomies) are not exclusion criteria) Pregnant and lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Kim
Phone
+14166035800
Email
jacob.kim@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Can Sarica, MD
Phone
+14377772269
Email
can.sarica@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mojgan Hodaie, MD, MSc
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Kim
Phone
+14166035800
Email
jacob.kim@uhn.ca
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andréanne Hamel
Phone
(819) 346-1110
Ext
16365
Email
andreanne.hamel@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Christian Iorio-Morin, MD, PhD

12. IPD Sharing Statement

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

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