Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - St. Joseph Mercy Oakland

Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Age Range:22 - 65
Start Date:March 2013
End Date:May 2014

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A Double-Blinded, Randomized, Sham-Controlled, Proof of Concept Study Exploring the Safety and Efficacy of RINCE Technology for the Treatment of Patients 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 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.

Inclusion Criteria:

- Patient must provide written informed consent and privacy authorization prior to
participation in the study. Patient must have the ability to read and/or follow
written and oral instructions, abide by the study restrictions, and agree to return
for the required assessments.

- 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.

- Patients must have a 24-hour recall pain intensity score at both the screening and
baseline visits between 40 and 90 inclusive on a 100 mm VAS scale.

- 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.

- Patients must be willing to refrain from all excluded therapies for the duration of
the study.

- In the opinion of the Investigator, the patient is willing and able to comply with
all protocol-specified requirements.

Exclusion Criteria:

- Patient has a current significant psychological or psychiatric disorder (e.g.,
severe, unstable or poorly controlled depression, severe anxiety or
obsessive-compulsive disorder; history of suicide attempt within preceding 5 years or
suicidal ideation within preceding 6 months; or any history of bipolar disorder,
schizophrenia, schizoaffective or other psychotic disorder).

- Patient has a score of 2 or 3 on item 9 of the BDI, or, based on the investigator's
judgment, the patient is at risk of suicidal ideation or behavior.

- Patient is currently using prohibited medications or treatments (see Prohibited
Concomitant Therapy section of protocol) including FDA-approved fibromyalgia
treatments, other centrally active analgesics, stimulants, anesthetic patches, CPAP
and/or TENS therapy.

- Patient has an active diagnosis and is being treated for chronic infection or chronic
condition such as lupus, rheumatoid arthritis, Parkinson's disease, multiple
sclerosis, hepatitis, polio, seizures, or cancer (other than basal or squamous cell
skin cancer).

- Patient has any other chronic pain condition other than fibromyalgia that, in the
Investigator's opinion, would interfere with the assessment of fibromyalgia (e.g.,
rheumatoid arthritis, post herpetic neuralgia, pain associated with diabetic
neuropathy, severe pain due to degenerative joint disease, etc.)

- Patient has history of seizure disorder, dementia or epilepsy anytime during his or
her life except pediatric febrile seizures.

- Female patient who is pregnant, planning a pregnancy, or breastfeeding.

- Patient has any other disease or medical condition that, in the opinion of the
investigator, would interfere with the evaluation of study device efficacy or safety,
or would compromise the patient's ability to participate in or complete the study.

- Patient has a history of other cranial electrical stimulation device use, or
electroconvulsive therapy.

- Patient has any metal implant, such as stents, aneurysm clips, shunts, pacemakers,
defibrillators or neurostimulators. Long-bone implants are not excluded.

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

- 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.

- Current systemic infection (e.g., HIV, hepatitis).

- Patients receiving systemic corticosteroids (> 5 mg prednisone or equivalent per

- Patients receiving regular or frequent opioids, opiates or narcotics.

- Pending or current litigation or disability claim (including Workman's Compensation).
Patients currently receiving disability benefits will require medical monitor
approval on a case-by-case basis.

- Patient has history of alcohol and/or drug abuse.

- Patient has participated in any investigational study within 30 days prior to
Screening visit or is currently participating in another clinical trial.

- Patient has received any prior experimental treatment or therapy that, in the opinion
of the medical monitor, would compromise the patient's ability to participate in the

- Patient is a staff member or relative of a staff member at either the investigative
site or the Cerephex Corporation.
We found this trial at
44405 Woodward Ave
Pontiac, Michigan 48341
(248) 858-3000
St. Joseph Mercy Oakland St. Joseph Mercy Oakland (SJMO) is a 443-bed comprehensive, community and...
Pontiac, MI
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