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

NCT ID: NCT02729480

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2022-10-01

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)

Conditions

Facial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continued Stimulation Group

Subjects randomized to this group will have the Halo Craniofacial Nerve Stimulator System activated immediately.

Group Type: EXPERIMENTAL

Halo Craniofacial Nerve Stimulator System

Intervention Type: DEVICE

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.

Delayed Continuation Group

Subjects randomized to this group with have the Halo Craniofacial Nerve Stimulator System activated after 90 days.

Group Type: ACTIVE_COMPARATOR

Halo Craniofacial Nerve Stimulator System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA

UNKNOWN

Sponsor Role: collaborator

International Spine, Pain and Performance Center, Washington DC, USA

UNKNOWN

Sponsor Role: collaborator

Minimally Invasive Pain Institute, Utica, New York, USA

UNKNOWN

Sponsor Role: collaborator

Case Western Reserve University, Cleveland, Ohio, USA

UNKNOWN

Sponsor Role: collaborator

Pennsylvania Hospital, Philadelphia, Pennsylvania, USA

UNKNOWN

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Prizm Pain Management, Canton, Michigan

UNKNOWN

Sponsor Role: collaborator

Curonix LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, United States

Goodman Campbell Brain and Spine, Indiana University

Indianapolis, Indiana, United States

Prizm Pain Management

Canton, Michigan, United States

Minimally Invasive Pain Institute

Utica, New York, United States

University Hospitals Case Medical Center, Department of Anesthesiology, Division of Pain Medicine

Cleveland, Ohio, United States

Pennsylvania Hospital, Dept. of Neurosurgery

Philadelphia, Pennsylvania, United States

baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

30-00208

Identifier Type: -

Identifier Source: org_study_id