Facial PainNCT02729480
Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
A study testing Halo Craniofacial Nerve Stimulator System in people with Facial Pain, run by Curonix LLC at 7 sites in United States.
Trial summary
The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Pain
- What is being tested?
- Halo Craniofacial Nerve Stimulator System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Feb 2017to 1 Oct 2022
- Phase
- Interventional
- 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
- Subject is ≥ 18 years of age at time of informed consent
- Subjects have been diagnosed with Cranial-facial pain with an average VAS > 5 (on a 0-10 scale) over the course of the last month based on baseline pain diary.
- Subject diagnosis with neuropathic cranial-facial pain refractory to conventional medical management for at least 12 months prior to enrollment;
- Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regimen for 3 months prior to study entry.
- Based on the medical opinion of the Principal Investigator, subject has a stable Tricyclic regimen for 3 months prior to study entry
- No medication overuse and not attributed to another causative disorder
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- Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
- Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure;
- Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- Subject is male or non-pregnant female as determined with a negative pregnancy test at baseline visit, and if sexually active, must be using a medically acceptable method of contraception for the duration of their study participation;
- Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures;
- Patient is capable of giving informed consent
Who cannot join
- A. Subject has undergone botulinum toxin (BOTOX) injections of the head and/or neck in the last 3 months.
- Unresolved Malignancies in last six months;
- Subject has a history of migraine, headaches of central origin or trigeminal autonomic cephalalgias;
- Subject has postherpetic neuralgia (shingles);
- Complete deafferentation of all branches of the trigeminal, facial, occipital nerves and cervical plexus;
- Subject has an active systemic infection or is immune-compromised;
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- Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
- Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
- Bleeding complications or coagulopathy issues;
- Pregnant/lactating or not using adequate birth control;
- A life expectancy of less than one year;
- Any active implanted device whether turned off or on;
- A previous peripheral nerve stimulator (PNS) experience for the treatment of facial pain including a failed trial or explanted device;
- Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures;
- Subject is currently involved in litigation regarding injury, or is receiving worker's compensation benefits.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Prizm Pain Management
Canton, Michigan, 48187
University Hospitals Case Medical Center, Department of Anesthesiology, Division of Pain Medicine
Cleveland, Ohio, 44106
baylor College of Medicine
Houston, Texas, 77030
Goodman Campbell Brain and Spine, Indiana University
Indianapolis, Indiana, 46202
Pennsylvania Hospital, Dept. of Neurosurgery
Philadelphia, Pennsylvania, 19106
Minimally Invasive Pain Institute
Utica, New York, 13502
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Multi-center, Prospective, Controlled, Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.
Read the detailed description
Subjects will be randomized at enrollment into either a delayed or immediate continuation group. The immediate continuation group will immediately continue with the stimulation after a 30-day trial period and will be monitored for a total of 12 months. The delayed activation group will have their device turned off after the 30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed activation group will have their devices reactivated.
Subjects will have neuropathic pain of various etiologies, including trauma, surgery or post-herpetic infections. Stimulators will be placed at the site target of the painful area, including the epifascial plane under the skin but above the muscles in the vicinity of the targeted branches of; A. Branches of Trigeminal Nerves in the Ophthalmic, Maxillary, or Mandibular B. Sensory branches of Facial Nerves C. Branches of the Occipital Nerves (Greater and/or Lesser) D. Branches of the Cervical Plexus (Superficial and/or Deep)
- Conditions
- Facial Pain
- Being tested
- Halo Craniofacial Nerve Stimulator System
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halo Craniofacial Nerve Stimulator SystemDevice
The Halo Craniofacial Nerve Stimulator System is a wirelessly powered neurostimulator for pain in the face or head (not for headaches or migraine). This technology includes an implanted stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin to the receiver.
| Study group | Role | What they receive |
|---|---|---|
| Continued Stimulation Group | Experimental | Subjects randomized to this group will have the Halo Craniofacial Nerve Stimulator System activated immediately. Receives: Device: Halo Craniofacial Nerve Stimulator System |
| Delayed Continuation Group | Active comparator | Subjects randomized to this group with have the Halo Craniofacial Nerve Stimulator System activated after 90 days. Receives: Device: Halo Craniofacial Nerve Stimulator System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS)
Measured: 3 months
Incidence and severity of adverse events
Measured: 3 months
Secondary outcomes (6)
Percentage change from baseline in VAS for facial pain
Measured: Baseline and 3 months
Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire
Measured: Baseline and 3 months
Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC)
Measured: 3 months
Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36
Measured: Baseline and 3 months
Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36
Measured: Baseline and 3 months
Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2)
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start1 Feb 2017
- Primary completion1 Feb 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curonix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA, International Spine, Pain and Performance Center, Washington DC, USA, Minimally Invasive Pain Institute, Utica, New York, USA, Case Western Reserve University, Cleveland, Ohio, USA, Pennsylvania Hospital, Philadelphia, Pennsylvania, USA, Baylor College of Medicine, Prizm Pain Management, Canton, Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729480
- Sponsor's protocol ID
- 30-00208
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2016
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified participant data for all primary endpoints will be made available within 6 months of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Controlled, Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02729480
- Acronym / sponsor ID
- 30-00208
- Conditions
- Facial Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Curonix LLCIndustry (pharma, biotech, devices)
- Collaborators
- Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA, International Spine, Pain and Performance Center, Washington DC, USA, Minimally Invasive Pain Institute, Utica, New York, USA, Case Western Reserve University, Cleveland, Ohio, USA, Pennsylvania Hospital, Philadelphia, Pennsylvania, USA, Baylor College of Medicine, Prizm Pain Management, Canton, Michigan
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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.
The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.
Detailed description
Subjects will be randomized at enrollment into either a delayed or immediate continuation group. The immediate continuation group will immediately continue with the stimulation after a 30-day trial period and will be monitored for a total of 12 months. The delayed activation group will have their device turned off after the 30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed activation group will have their devices reactivated.
Subjects will have neuropathic pain of various etiologies, including trauma, surgery or post-herpetic infections. Stimulators will be placed at the site target of the painful area, including the epifascial plane under the skin but above the muscles in the vicinity of the targeted branches of; A. Branches of Trigeminal Nerves in the Ophthalmic, Maxillary, or Mandibular B. Sensory branches of Facial Nerves C. Branches of the Occipital Nerves (Greater and/or Lesser) D. Branches of the Cervical Plexus (Superficial and/or Deep)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continued Stimulation Group | Experimental | Device: Halo Craniofacial Nerve Stimulator SystemSubjects randomized to this group will have the Halo Craniofacial Nerve Stimulator System activated immediately. |
| Delayed Continuation Group | Active comparator | Device: Halo Craniofacial Nerve Stimulator SystemSubjects randomized to this group with have the Halo Craniofacial Nerve Stimulator System activated after 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is ≥ 18 years of age at time of informed consent
- Subjects have been diagnosed with Cranial-facial pain with an average VAS > 5 (on a 0-10 scale) over the course of the last month based on baseline pain diary.
- Subject diagnosis with neuropathic cranial-facial pain refractory to conventional medical management for at least 12 months prior to enrollment;
- Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regimen for 3 months prior to study entry.
- Based on the medical opinion of the Principal Investigator, subject has a stable Tricyclic regimen for 3 months prior to study entry
Key exclusion criteria (16 listed)
- A. Subject has undergone botulinum toxin (BOTOX) injections of the head and/or neck in the last 3 months.
- Unresolved Malignancies in last six months;
- Subject has a history of migraine, headaches of central origin or trigeminal autonomic cephalalgias;
- Subject has postherpetic neuralgia (shingles);
- Complete deafferentation of all branches of the trigeminal, facial, occipital nerves and cervical plexus;
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 |
|---|---|---|
| Halo Craniofacial Nerve Stimulator SystemThe Halo Craniofacial Nerve Stimulator System is a wirelessly powered neurostimulator for pain in the face or head (not for headaches or migraine). This technology includes an implanted stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin to the receiver. | Device | Continued Stimulation Group, Delayed Continuation Group |
Primary outcome
Pain Score
Time frame: 3 months
To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS)
Incidence and severity of adverse events
Time frame: 3 months
6 secondary outcomes
Percentage change from baseline in VAS for facial pain
Time frame: Baseline and 3 months
Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire
Time frame: Baseline and 3 months
Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC)
Time frame: 3 months
Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36
Time frame: Baseline and 3 months
Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36
Time frame: Baseline and 3 months
Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2)
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: Yes. De-identified participant data for all primary endpoints will be made available within 6 months of study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Halo Craniofacial Nerve Stimulator System in people with Facial Pain, run by Curonix LLC at 7 sites in United States.
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 13 inclusion and 16 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: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 3 months). The study lists 2 primary outcomes in all. 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 12 Oct 2023.