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Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301 — PERRFECT-301  

Fibromyalgia Clinical Trial

Official title:
A Double-Blinded, Randomized, Sham-Controlled, Pivotal Study of the NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia

Clinical Trial Summary

The purpose of this study is to test the safety and efficacy of a noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 200 fibromyalgia patients will be randomized into one of two study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all, while the other group will receive active RINCE treatment. The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' weekly worst pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02211508
Study type Interventional
Source Cerephex Corporation
Contact
Status Terminated
Phase N/A
Start date July 2014
Completion date February 2015
View Details
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