Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain

Facial Pain Clinical Trial

Official title:

Multi-center, Prospective, Controlled, Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729480
• Other study ID #: 30-00208
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2023
• Source: Stimwave Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain
• Neuralgia

Intervention

Device:
• Halo Craniofacial Nerve Stimulator System
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.

Locations

Country	Name	City	State
United States	Prizm Pain Management	Canton	Michigan
United States	University Hospitals Case Medical Center, Department of Anesthesiology, Division of Pain Medicine	Cleveland	Ohio
United States	baylor College of Medicine	Houston	Texas
United States	Goodman Campbell Brain and Spine, Indiana University	Indianapolis	Indiana
United States	Pennsylvania Hospital, Dept. of Neurosurgery	Philadelphia	Pennsylvania
United States	Minimally Invasive Pain Institute	Utica	New York
United States	International Spine, Pain & Performance Center	Washington	District of Columbia

Sponsors (8)

Lead Sponsor	Collaborator
Stimwave Technologies	Baylor College of Medicine, Case Western Reserve University, Cleveland, Ohio, USA, 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, Pennsylvania Hospital, Philadelphia, Pennsylvania, USA, Prizm Pain Management, Canton, Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS)	3 months
Primary	Incidence and severity of adverse events		3 months
Secondary	Percentage change from baseline in VAS for facial pain		Baseline and 3 months
Secondary	Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire		Baseline and 3 months
Secondary	Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC)		3 months
Secondary	Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36		Baseline and 3 months
Secondary	Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36		Baseline and 3 months
Secondary	Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2)		Baseline and 3 months