Trigeminal NeuralgiaPhase 1/2FreeSTNCT05615714
Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial)
A Phase 1/2 study testing Paresthesia-free Peripheral Nerve Field Stimulation in people with Trigeminal Neuralgia and Facial Pain, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia, Facial Pain
- What is being tested?
- Paresthesia-free Peripheral Nerve Field Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Oct 2022to 28 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Andréanne Hamel, (819) 346-1110 ext. 16365, andreanne.hamel@usherbrooke.ca
Christian Iorio-Morin, MD, PhD
- Recruiting
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
Jakob Kim, +14166035800, jacob.kim@uhn.ca
About this study
Official title: Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia: a Double-blinded, Randomized Trial (FreeST Trial)
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
Read the 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.
- Conditions
- Trigeminal Neuralgia, Facial Pain
- Being tested
- Paresthesia-free Peripheral Nerve Field Stimulation, Sham stimulation
- Keywords
- Peripheral Nerve Field Stimulation
- Medical subject headings
- Trigeminal Neuralgia, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paresthesia-free Peripheral Nerve Field StimulationOther
High frequency and sub-paresthesia threshold intensity parameters will be used for paresthesia-free stimulation of trigeminal nerve branches.
Sham stimulationOther
Stimulation will be turned off.
| Study group | Role | What they receive |
|---|---|---|
| Paresthesia-Free Stimulation | Experimental | Duration: 2 weeks Receives: Other: Paresthesia-free Peripheral Nerve Field Stimulation |
| Sham Stimulation | Sham comparator | Duration: 2 weeks Receives: Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative week 2 to week 6
Secondary outcomes (10)
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.
Measured: Postoperative week 0 to week 6
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.
Measured: Postoperative week 0 to week 6
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.
Measured: Postoperative week 0 to week 6
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.
Measured: Postoperative week 0 to week 6
Adverse effect Profile
Adverse effect Profile
Measured: Postoperative week 0 to month 12
Ratio of patients who chose paresthesia-free or paresthesia-inducing stimulation at week 6, month 6 and 12
paresthesia-free or paresthesia-inducing stimulation
Measured: Postoperative week 6, month 6 and 12
fMRI BOLD signal change
IPG ON>OFF BOLD signal change (both paresthesia-free and Paresthesia-inducing conditions will be tested)
Measured: Between postoperative month 6 and 12
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.
Measured: Postoperative month 6 and 12
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.
Measured: Postoperative month 6 and 12
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.
Measured: Postoperative month 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start28 Oct 2022
- Primary completion28 Oct 2024 (estimated)
- Study completion28 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mojgan Hodaie, University Health Network, Toronto
- Investigators
- Mojgan Hodaie, MD, MSc, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615714
- Sponsor's protocol ID
- 21-6219
- Acronym
- FreeST
- Status last verified
- Feb 2024
- First submitted
- 30 Oct 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia: a Double-blinded, Randomized Trial (FreeST Trial)
- ClinicalTrials.gov ID
- NCT05615714
- Acronym / sponsor ID
- FreeST / 21-6219
- Conditions
- Trigeminal Neuralgia, Facial Pain
- Keywords
- Peripheral Nerve Field Stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 28 Oct 2024 (estimated)
- Study completion
- 28 Oct 2024 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paresthesia-Free Stimulation | Experimental | Other: Paresthesia-free Peripheral Nerve Field StimulationDuration: 2 weeks |
| Sham Stimulation | Sham comparator | Other: Sham stimulationDuration: 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paresthesia-free Peripheral Nerve Field StimulationHigh frequency and sub-paresthesia threshold intensity parameters will be used for paresthesia-free stimulation of trigeminal nerve branches. | Other | Paresthesia-Free Stimulation |
| Sham stimulationStimulation will be turned off. | Other | Sham Stimulation |
Primary outcome
Visual Analogue Scale (VAS) Score Change
Time frame: Postoperative week 2 to week 6
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.
10 secondary outcomes
Visual Analogue Scale (VAS) Score Change
Time frame: Postoperative week 0 to week 6
Barrow Neurological Institute (BNI) pain intensity score change
Time frame: Postoperative week 0 to week 6
Brief Pain Inventory (BPI) score change
Time frame: Postoperative week 0 to week 6
Clinician and Patient Global Impression of Change Scale and Patient satisfaction scale score change
Time frame: Postoperative week 0 to week 6
Adverse effect Profile
Time frame: Postoperative week 0 to month 12
Ratio of patients who chose paresthesia-free or paresthesia-inducing stimulation at week 6, month 6 and 12
Time frame: Postoperative week 6, month 6 and 12
fMRI BOLD signal change
Time frame: Between postoperative month 6 and 12
Visual Analogue Scale (VAS) Score Change
Time frame: Postoperative month 6 and 12
Barrow Neurological Institute (BNI) pain intensity score change
Time frame: Postoperative month 6 and 12
Brief Pain Inventory (BPI) score change
Time frame: Postoperative month 6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mojgan Hodaie, MD, MSc principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paresthesia-free Peripheral Nerve Field Stimulation in people with Trigeminal Neuralgia and Facial Pain, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Kim (+14166035800, jacob.kim@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Score Change (time frame: Postoperative week 2 to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.