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

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ClinicalTrials.gov Identifier: NCT02729480
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : April 8, 2019
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • Pain Score [ Time Frame: 3 months ]
    To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS)
  • Incidence and severity of adverse events [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02729480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
  • Percentage change from baseline in VAS for facial pain [ Time Frame: Baseline and 3 months ]
  • Percent change from baseline in the Brief Pain Inventory-facial (BPIF) Questionnaire [ Time Frame: Baseline and 3 months ]
  • Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC) [ Time Frame: 3 months ]
  • Change from baseline in quality of life, Physical component score using Medical Outcomes Short Form SF-36 [ Time Frame: Baseline and 3 months ]
  • Change from baseline in quality of life, Mental component score using Medical Outcomes Short Form SF-36 [ Time Frame: Baseline and 3 months ]
  • Change from baseline in pain rating index from the Short Form McGill Pain Questionnaire (MPQ-SF-2) [ Time Frame: Baseline and 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
Official Title  ICMJE Multi-center, Prospective, Controlled, Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Facial Pain
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Continued Stimulation Group
    Subjects randomized to this group will have the Halo Craniofacial Nerve Stimulator System activated immediately.
    Intervention: Device: Halo Craniofacial Nerve Stimulator System
  • Active Comparator: Delayed Continuation Group
    Subjects randomized to this group with have the Halo Craniofacial Nerve Stimulator System activated after 90 days.
    Intervention: Device: Halo Craniofacial Nerve Stimulator System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2017)
65
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2016)
100
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Niek Vanquathem 0032 492 69 22 23 niek@freedomneuro.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02729480
Other Study ID Numbers  ICMJE 30-00208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party StimRelieve, LLC
Study Sponsor  ICMJE StimRelieve, LLC
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account StimRelieve, LLC
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP