Clinical trial NCT02729480: Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
Official title: Multi-center, Prospective, Controlled, Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Pain
Lead sponsor: Curonix LLC
Sponsor class: INDUSTRY
Collaborators: name: Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA
name: International Spine, Pain and Performance Center, Washington DC, USA
name: Minimally Invasive Pain Institute, Utica, New York, USA
name: Case Western Reserve University, Cleveland, Ohio, USA
name: Pennsylvania Hospital, Philadelphia, Pennsylvania, USA
name: Baylor College of Medicine
name: Prizm Pain Management, Canton, Michigan
First posted: 2016-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Pain Score
timeFrame: 3 months
measure: Incidence and severity of adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Percentage change from baseline in VAS for facial pain
timeFrame: Baseline and 3 months
measure: Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire
timeFrame: Baseline and 3 months
measure: Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC)
timeFrame: 3 months
measure: Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36
timeFrame: Baseline and 3 months
measure: Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36
timeFrame: Baseline and 3 months
measure: Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2)
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: International Spine, Pain & Performance Center
state: District of Columbia
city: Indianapolis
country: United States
facility: Goodman Campbell Brain and Spine, Indiana University
state: Indiana
city: Canton
country: United States
facility: Prizm Pain Management
state: Michigan
city: Utica
country: United States
facility: Minimally Invasive Pain Institute
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center, Department of Anesthesiology, Division of Pain Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Hospital, Dept. of Neurosurgery
state: Pennsylvania
city: Houston
country: United States
facility: baylor College of Medicine
state: Texas
Study officials:
References: