The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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
Pain Score
To achieve a sustained 50% reduction in pain measured by the Visual Analog Scale (VAS)
Time frame: 3 months
Incidence and severity of adverse events
Time frame: 3 months
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
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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