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

• Sponsor: StimRelieve, LLC
• 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
• Information provided by (Responsible Party): StimRelieve, LLC

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Facial Pain	Device: Halo Craniofacial Nerve Stimulator System	Not Applicable

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

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	65 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Multi-center, Prospective, Controlled, Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
Actual Study Start Date :	February 1, 2017
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Continued Stimulation Group; Subjects randomized to this group will have the Halo Craniofacial Nerve Stimulator System activated immediately.	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.
Active Comparator: Delayed Continuation Group; Subjects randomized to this group with have the Halo Craniofacial Nerve Stimulator System activated after 90 days.	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.

Outcome Measures

Primary Outcome Measures :

1. Pain Score [ Time Frame: 3 months ]
   To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS)
2. Incidence and severity of adverse events [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Percentage change from baseline in VAS for facial pain [ Time Frame: Baseline and 3 months ]
2. Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire [ Time Frame: Baseline and 3 months ]
3. Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 3 months ]
4. Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36 [ Time Frame: Baseline and 3 months ]
5. Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36 [ Time Frame: Baseline and 3 months ]
6. Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2) [ Time Frame: Baseline and 3 months ]

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Contacts

Layout table for location contacts

Contact: Niek Vanquathem	0032 492 69 22 23	niek@freedomneuro.com

Locations

Layout table for location information

United States, District of Columbia
International Spine, Pain & Performance Center	Recruiting
Washington, District of Columbia, United States, 20037
Contact: Juline Panneerselvam 202-808-8295 schedule@isppcenter.com
Principal Investigator: Mehul Desai
United States, Indiana
Goodman Campbell Brain and Spine, Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Pencek 317-396-1286 jpencek@goodmancampbell.com
Principal Investigator: Albert LEE, MD
United States, Michigan
Prizm Pain Management	Recruiting
Canton, Michigan, United States, 48187
Contact: Sikar Grewal 248-564-1485 sikar_grewal@yahoo.com
Principal Investigator: Jeffrey Rosenberg, MD
United States, New York
Minimally Invasive Pain Institute	Recruiting
Utica, New York, United States, 13502
Contact: Mary Sullivan 315-798-8737 ext 215 Mary.Sullivan@killpain.com
Principal Investigator: Nameer Haider
United States, Ohio
University Hospitals Case Medical Center, Department of Anesthesiology, Division of Pain Medicine	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Carmen Czich 216-983-5124 Carmen.Czich@UHhospitals.org
Principal Investigator: Salim Hayek, MD
United States, Pennsylvania
Pennsylvania Hospital, Dept. of Neurosurgery	Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Marie Kerr 215-829-6720 kerrm@uphs.upenn.edu
Principal Investigator: John Y Lee, MD
United States, Texas
baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Melyssa Fink 713-798-1037 Melyssa.Fink@bcm.edu
Principal Investigator: Ashwin Viswanathan, MD

Sponsors and Collaborators

StimRelieve, LLC

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

More Information

Layout table for additonal information

Responsible Party:	StimRelieve, LLC
ClinicalTrials.gov Identifier:	NCT02729480 History of Changes
Other Study ID Numbers:	30-00208
First Posted:	April 6, 2016
Last Update Posted:	April 19, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	De-identified participant data for all primary endpoints will be made available within 6 months of study completion.

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		Yes
Pediatric Postmarket Surveillance of a Device Product:		No

Additional relevant MeSH terms:

Layout table for MeSH terms

Neuralgia; Facial Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases	Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms