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

NCT02729480 | Completed DMC FDA Device

• 1 other identifier: 30-00208
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Facial Pain

Outcome Measures

Primary Outcomes (2)

• Pain Score

  To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS)

  3 months

• Incidence and severity of adverse events

  3 months

Secondary Outcomes (6)

• Percentage change from baseline in VAS for facial pain

  Baseline and 3 months

• Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire

  Baseline and 3 months

• Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC)

  3 months

• Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36

  Baseline and 3 months

• Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36

  Baseline and 3 months

Study Arms (2)

Continued Stimulation Group

EXPERIMENTAL

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

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.

Device: Halo Craniofacial Nerve Stimulator System

Interventions

Halo Craniofacial Nerve Stimulator System 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.

Continued Stimulation Group; Delayed Continuation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Curonix LLC: lead
• Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA: collaborator
• International Spine, Pain and Performance Center, Washington DC, USA: collaborator
• Minimally Invasive Pain Institute, Utica, New York, USA: collaborator
• Case Western Reserve University, Cleveland, Ohio, USA: collaborator
• Pennsylvania Hospital, Philadelphia, Pennsylvania, USA: collaborator
• Baylor College of Medicine: collaborator
• Prizm Pain Management, Canton, Michigan: collaborator

Study Sites (7)

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, 20037, United States

Location

Goodman Campbell Brain and Spine, Indiana University

Indianapolis, Indiana, 46202, United States

Location

Prizm Pain Management

Canton, Michigan, 48187, United States

Location

Minimally Invasive Pain Institute

Utica, New York, 13502, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

Pennsylvania Hospital, Dept. of Neurosurgery

Philadelphia, Pennsylvania, 19106, United States

Location

baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 6, 2016
• Study Start: February 1, 2017
• Primary Completion: February 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (7)