Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202

Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Age Range:22 - 75
Start Date:November 2015
End Date:July 29, 2016

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A Double-Blinded, Randomized, Sham-Controlled, Study of the Revised NeuroPoint Device for the Treatment of Pain Associated With Fibromyalgia

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.

Inclusion Criteria:

- Patient is male or female, 22 to 75 years of age, inclusive.

- Patient has a diagnosis of primary fibromyalgia as defined by the 2010 American
College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia.

- At screening, the patient scores between 40 and 90 on a visual analog scale 24-hour
recall pain scale, and between 4 and 9 inclusive on an 11 point numerical rating

- If female, is either not of childbearing potential or is willing to utilize specified
practices throughout the study to prevent becoming pregnant.

- Patient is willing and able to refrain or withdraw from the following therapies for
the duration of the study: duloxetine, milnacipran, pregabalin, gabapentin,
naltrexone, sodium oxybate, and opiates.

- Qualified patients with mild or moderate depression must be clinically stable, without
risk of suicidal ideation or behavior, and the dose of allowed anti-depressants should
have been stable for at least three months prior to the Baseline clinic visit.

- Patient is willing and able to comply with all protocol-specified requirements.

- Patient is capable of reading and understanding English and has provided written
informed consent to participate.

Exclusion Criteria:

- The patient suffers from one or more of clinically significant psychiatric condition
that could interfere with the patient's well-being or ability to comply with the

- Patient has a Beck Depression Inventory-II total score greater than 25 at either the
Screening visit or Baseline clinic visit.

- The patient is at increased risk of suicide.

- Patient is unable, unwilling or not advised to refrain from or discontinue prohibited
medications or treatments.

- Patient has a diagnosis of, or is being treated for, systemic lupus erythematosus,
inflammatory arthritis, or other documented systemic autoimmune disorder, Parkinson's
disease, multiple sclerosis, or cancer (other than basal or squamous cell skin

- Patient has any other chronic pain condition that, in the Investigator's or Sponsor's
opinion, could interfere with the patient's assessment of his/her fibromyalgia status.

- Patient has a history of severe, refractory or uncontrolled migraine headaches,
seizure disorder or clinically significant cognitive dysfunction.

- Patient is pregnant or planning to become pregnant within the next 6 months.

- Patient has a body mass index greater than 45 at the Screening visit.

- Patient meets any of the study's exclusionary laboratory criteria.

- Patient has any other disease or medical condition that, in the opinion of the
Investigator or Sponsor, could endanger the patient, interfere with the evaluation of
the study device's efficacy or safety, or compromise the patient's ability to comply
with/complete the study.

- Patient has a history of cranial electrical stimulation or transcutaneous magnetic
stimulation within 2 years of screening, or electroconvulsive therapy within 5 years
of screening; patient was enrolled in the Sponsor's previous NPT-301 study and
received greater than 12 stimulation treatments.

- Patient has a metal implant at or above the level of the 7th cervical vertebra, a
cardiac pacemaker or defibrillator, or vagus nerve stimulator.

- Any recent surgery or anticipated need for surgery that might confound results or
interfere with patient's ability to comply with the protocol.

- Myocardial infarction during the 12 months prior to screening, uncontrolled
hypertension, active cardiac disease, clinically significant cardiac rhythm or
conduction abnormality, or anticipation of bypass or other cardiac surgery within the
next 12 months.

- Current systemic infection (e.g., HIV, hepatitis B or C; Lyme disease).

- Patient is receiving systemic corticosteroids greater than 5 mg prednisone or
equivalent per day.

- Patient is using opiates on a regular or frequent basis.

- Pending or current litigation or disability claim (including Workman's Compensation).

- History of significant alcohol and/or drug abuse or dependency within preceding 5
years, or a positive result on the screening (or subsequent) drug screen indicating
use of an illicit substance.

- Patient has participated in an investigational study of a therapeutic treatment within
90 days prior to Screening visit or is currently participating in another clinical

- Patient is a staff member or relative of a staff member at either the investigative
site or the sponsor.
We found this trial at
Chicago, Illinois 60634
Chicago, IL
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Birmingham, Alabama 35216
(205) 757-8208
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Sacramento, California 95825
Sacramento, CA
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Williamsville, NY
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