C2 Nerve Field Stimulation for the Treatment of XXXX : A Prospective, Double-blind, Randomized, Controlled Cross-over Study.

@entity1 @entity239 @entity2794 @entity158
BACKGROUND: @entity239 is a condition characterized by widespread chronic @entity158 . Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of @entity1 . C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary @entity2794 . Small C2 pilot studies seem to be beneficial in @entity239 . METHODS: Forty @entity1 were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The @entity1 underwent 2 week periods of different doses of stimulation consisting of minimal (.1  mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven @entity1 received a permanent implant and 25 completed the 6 month open label follow up period. RESULTS: During the 6 week trial phase of the study, @entity1 had an overall decrease of 36% on the @entity239 impact questionnaire (FIQ), a decrease of 33% @entity239 @entity158 and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six  percent of @entity1 were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. CONCLUSION: Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable @entity1 with @entity239 .
