A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of Michigan

A Phase 2 Clinical Trial Evaluating Use of the NeuroPoint Medical Device as a Treatment for Fibromyalgia.

The purpose of this study is to evaluate the mechanisms of 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 20 patients will receive a combination of active and inactive (sham) therapy treatments over a 16-week period followed by a 4 week post-treatment evaluation. Patients will also undergo three (3) functional brain imaging scans while participating in the study: the first prior to the commencement of treatment, another mid-treatment; and the third at the completion of the treatment period.

The study's primary outcome measure will be the change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a change in pain intensity as well brain functioning. We do not expect there to be a statistically significant improvement in pain intensity due to the small sample but do expect to see statistically significant changes in cortical function as measured by EEG and fMRI

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 female, 18-65 years of age (inclusive) at the time of consent.
• Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 diagnostic 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 patient of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation.
• 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.
• Participants undergoing fMRI and 1H-MRS must be predominantly right handed (i.e. the subject writes with their right hand).

Exclusion Criteria:

The patient will not be eligible for enrollment if there is any history of, or in the opinion of the investigator, any of the following criteria are met:

• 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 total Hospital and Anxiety Depression score of 11-21 for either anxiety or depression, 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 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, neurostimulators or other contraindications with fMRI and 1H-MRS. 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 day).
• 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 study.
• Patient is a staff member or relative of a staff member at either the investigative site or the Cerephex Corporation.
• Body Mass Index (BMI) of greater than approximately 40 kg/m2.
• Claustrophobia or any other factor sufficiently significant that it is likely to prevent successful completion of fMRI and 1H-MRS procedures.