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Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202

NCT02613949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-01-26

No results posted yet for this study

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 45 fibromyalgia patients will be randomized into one of three study groups. One of these groups will receive sham treatment, meaning they will receive no treatment at all. A second group will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A third group will receive active RINCE treatment at a higher than nominal signal amplitude level (treatment mode 2). The study's primary outcome measure will be the difference between active and sham treatment groups in the mean change from baseline in patients' 24-hour recall average pain scores. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.

Conditions

  • Fibromyalgia

Interventions

DEVICE

RINCE

The NeuroPoint device is used to deliver repeat applications of RINCE therapy

Sponsors & Collaborators

  • Cerephex Corporation

    lead INDUSTRY

Principal Investigators

  • R. Michael Gendreau, MD PhD · Cerephex Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-07-08
Completion
2016-07-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613949 on ClinicalTrials.gov