Completed

PERRFECT-SJMOA Double-Blinded, Randomized, Sham-Controlled, Proof of Concept Study Exploring the Safety and Efficacy of RINCE Technology for the Treatment of Patients With Fibromyalgia

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What is being tested

RINCE

+ RINCE

+ RINCE

Device
Who is being recruted

Muscular Diseases+7

+ Musculoskeletal Diseases

+ Nervous System Diseases

From 22 to 65 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorCerephex Corporation
Last updated: September 17, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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 management of fibromyalgia. Patients who meet the 1990 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, while the remaining two groups will receive different amounts of RINCE therapy. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a difference between treatment groups in primary outcome measure.

NCT01825954
Principal SponsorCerephex Corporation
Last updated: September 17, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFibromyalgiaPain

Criteria

7 inclusion criteria required to participate
Female patients of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation. Acceptable birth control includes a vasectomized partner, contraceptives (oral, parenteral, or transdermal), intrauterine device, or double barrier method including condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream. Patients considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or greater than one year post-menopausal, defined as a complete cessation of menstruation for at least one year
In the opinion of the Investigator, the patient is willing and able to comply with all protocol-specified requirements
Patient is male or female, 22-65 years of age (inclusive) at the time of consent
Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 classification criteria for fibromyalgia
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20 exclusion criteria prevent from participating
Any anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol
Current systemic infection (e.g., HIV, hepatitis)
Female patient who is pregnant, planning a pregnancy, or breastfeeding
Myocardial infarction during preceding 12 months, uncontrolled hypertension, active cardiac disease (American Heart Association Functional Class 2, 3 or 4 or Objective Class C or D), clinically significant cardiac rhythm or conduction abnormality, or anticipation of bypass or other cardiac surgery within the next 12 months
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
RINCE - active RINCE therapy involving 24 total treatment applications from NeuroPoint device

Group II

Active Comparator
RINCE - active RINCE therapy involving 16 total treatment applications from NeuroPoint device, followed by 8 sham applications from the NeuroPoint device

Group III

Sham
Sham RINCE - sham RINCE therapy involving 24 total sham applications from NeuroPoint device

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St. Joseph Mercy Oakland

Pontiac, United StatesOpen St. Joseph Mercy Oakland in Google Maps
CompletedOne Study Center