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Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study — PERRFECT  

Fibromyalgia Clinical Trial

Official title:
An Open Label Extension Trial for Patients With Fibromyalgia Who Complete Study NPT-201 (NCT01825954) and Who Experience Inadequate Pain Reduction

Clinical Trial Summary

The purpose of this open label study is to provide up to 24 active treatments of noninvasive cortical electrostimulation therapy only to those fibromyalgia patients who experienced inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201 (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol as that used in active treatment arms of NPT-201. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. The study will provide active treatment to those participants who received sham therapy in NPT-201, and will test whether or not additional therapy applications might further improve pain in those participants who previously received active therapy, but did not achieve adequate pain relief.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01958853
Study type Interventional
Source Cerephex Corporation
Contact
Status Completed
Phase N/A
Start date August 2013
Completion date May 2014
View Details
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