Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacia… (NCT02729480) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain
United States60 participantsStarted 2017-02-01
Plain-language summary
The purpose of this study is to assess the effectiveness of craniofacial nerve stimulation for the treatment of neuropathic pain.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…