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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

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)


Sponsor: StimRelieve, LLC

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: StimRelieve, LLC

Dates:
Date Received: March 29, 2016
Date Started: February 1, 2017
Date Completion: November 2018
Last Updated: April 12, 2017
Last Verified: April 2017