Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 301

Inclusion Criteria:

- Patient is male or female, 22 to 65 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.

- 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
protocol.

- 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
cancer).

- 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 40 at the Screening visit.

- 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 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 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 trial.