Treatment Studies

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Fibromyalgia Pain Relief with Portable Neuromodulation Device

RELIEF clinical trial will evaluate safety and determine the effectiveness of the PRIMA device to significantly reduce fibromyalgia pain.

Device: The Model 801 PRIMA is a portable unit that is the size of a cassette player with attaching headphones.

Manufacturer and Sponsor: Fralex Therapeutics, Inc. of Toronto, Ontario, Canada

FDA Status: The FDA has not approved the PRIMA device for any use in the United States. It is being tested in a pivitol (Phase III) trial under an Investigational Device Exemption (IDE) from the FDA.

European Status: The PRIMA device has been granted CE marketing, which allows the sale and distribution of the product in Europe.

Basic Info: During the past few years, pain researchers have explored the use of magnetic fields or pulses, as well as small currents that are applied to the brain’s outer cortex to alter the function of the cells beneath. Unlike taking pain medications, these devices have the potential to favorably modify brain function while ideally minimizing systemic side effects. Transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and the complex neural pulse (CNP) are three such therapies being investigated in this category for the treatment of fibromyalgia pain. The PRIMA device is the first to employ CNP and differs from the other two types of technology in the following important ways:

• It does not produce an electric current in the manner that tDCS works (i.e., no electrons pass through the tissues).
• The magnetic field generated by the PRIMA device is much lower powered than TMS, which allows the generator to be a portable home unit. The higher powered TMS units require that patients attend a clinical setting for treatment due to the large size of the generator (an inconvenience for patients).
• Magnetic field strength produced by the device is less than the industry limits for electric hair dryers.
• The shape of the wave-forms and pulsing frequency used by the PRIMA device in this study are custom designed to interact specifically with the brain centers involved for a particular condition. Separate wave-forms have been designed for pain, depression and anxiety. In other words, CNP is not a "one-shoe-fits-all" type of technology.

Patients simply put the headsets on for 40 minutes twice a day and turn on the generator unit (the size of a portable cassette player) to receive their therapy. The headset rests above the ears, so patients may listen to music, watch TV, or engage in other sedentary activities while receiving therapy. The PRIMA device does not make any noise, emit light or produce any detectible sensation. This makes it comfortable to wear for the 40-minute treatment session and also means that it is easy to blindly test the function of the device against an identical one that has been electronically disabled (e.g., to provide a placebo or sham model).

Recruiting for Phase III Trial: A 12-week placebo-controlled study is ongoing to primarily determine the effectiveness of the PRIMA device to reduce fibromyalgia pain. Its effect on mood, sleep quality, and physical functioning will also be assessed. Twelve cities in the United States and four in Canada are recruiting a total of 200 fibromyalgia patients for the study. Participants must visit the trial center seven times during the study and they have a 50% chance of receiving the "sham" or disabled device.

Previous Testing: Two small reports have been published in the medical journals on the potential for the PRIMA device to relieve pain in fibromyalgia.^1,2 No side effects occurred, although the number of patients studied was small and trial durations were short. The PRIMA device has already been approved for marketing in Europe because the European approval process focuses on safety (almost 400 people were involved in the safety testing). However, Fralex plans to market the device in Europe after the ongoing Phase III trials in the United States and Canada are completed.

Study Criteria (key requirements):

• Must meet the diagnostic criteria for fibromyalgia
• Male or female, 18 years or older
• Must be willing to discontinue all medications for pain, mood, and sleep disorders except for acetaminophen and cardiac aspirin (up to 325 mg per day)
• Cannot have any of the following:
  • autoimmune or inflammatory disease
    
  • major depressive disorder and other psychiatric conditions
    
  • history or current treatment for cancer, seizure disorder, or migraine
    
  • hearing aids, pacemakers, or metal implants above mid-torso (except dental work)

Complete details for trial eligibility can be found at www.clinicaltrials.gov. More information about Fralex Therapeutics, Inc. can be found online at www.fralex.com.

Study Locations in the United States:

California

Garden Grove, CA
CNS Network
Ask for Fralex/PRIMA device study coordinator
Phone: (866) 787-4257

Lancaster, CA 93534
Coordinator: Eric James Shaver, D.C. (ask for Becky Iglesias)
Phone: (661) 726-1515

Palmdale, CA 93550
Coordinator: Luigi Kirchmann, D.C. (ask for Becky Iglesias)
Phone: (661) 726-1515

La Jolla, CA 92037
Call Fralex toll-free at (877) 213-8118

Florida

Gainesville, FL
Center for Musculoskeletal Pain Research
Ask for Fralex/PRIMA device study coordinator
Phone: (352) 265-8901

Winter Park, FL 32789
Call Fralex toll-free at (877) 213-8118

West Palm Beach, FL 33409
Coordinators: Eric Cota and Shirley Zahn
Phone: (561) 689-0606

Kentucky

Lexington, KY
The Pain Treatment Center
Ask for Fralex/PRIMA device study coordinator
Phone: (859) 260-2467

Minnesota

Rochester, MN 55905
Call Fralex toll-free at (877) 213-8118

New York

New York, NY 10003
Coordinator: Lisa Shichijo
Phone: (212) 844-8533

Rochester, NY 14642
Coordinator: Lisa Bailey, RN
Phone: (585) 273-5199

North Carolina

Winston-Salem, NC 27103
Call Fralex toll-free at (877) 213-8118

Pennsylvania

Altoona, PA 16602
Coordinator: Vickie Lassak
Phone: (814) 940-2000 option 5

Washington

Spokane, WA 99216
Call Fralex toll-free at (877) 213-8118

Seattle, WA 99104
Call Fralex toll-free at (877) 213-8118

Study Locations in Canada:

Toronto, Ontario M9W 4L6
Manna Research Center
Phone: (416) 740-2895

Toronto, Ontario M2N 6K7
Call Fralex toll-free at (877) 213-8118

Hamilton, Ontario L8N 6K7
Call Fralex toll-free at (877) 213-8118

Ottawa, Ontario K1H 1A2
Call Fralex toll-free at (877) 213-8118

1. Thomas AW, et al. Pain Res Manage 11(2):85-90, 2006.
2. Thomas AW, et al. Pain Res Manage 12(4):249-258, 2007.

The Fibromyalgia Network is not in any way associated with any clinical trials, pharmaceutical companies, device manufacturers, or government agencies. As a self-help organization, we accept no sponsorship, advertisements, or government funds. The information on these pages is provided as a public service.

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