A Phase 1/2 interventional study of Paresthesia-free Peripheral Nerve Field Stimulation and Sham stimulation in Trigeminal Neuralgia and Facial Pain, sponsored by University Health Network, Toronto. Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by University Health Network, Toronto · Phase 1/2, Interventional, and Treatment
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
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.
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Duration: 2 weeks
Other: Paresthesia-free Peripheral Nerve Field Stimulation
Duration: 2 weeks
Other: Sham stimulation
High frequency and sub-paresthesia threshold intensity parameters will be used for paresthesia-free stimulation of trigeminal nerve branches.
Stimulation will be turned off.
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.
Time frame: Postoperative week 2 to week 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative week 0 to week 6
Adverse effect Profile
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
paresthesia-free or paresthesia-inducing stimulation
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative month 6 and 12
Started Oct 2022 (actual). Primary completion is estimated for Oct 2024, 24 months after the start.
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