EMF eases fatigue in MS patients
Device currently unavailable in U.S.
A device no bigger than a man’s wristwatch delivers a pulsed electromagnetic field (EMF) that two separate studies have found reduces the debilitating fatigue common to many multiple sclerosis (MS) patients.
The Enermed device was developed to relieve migraine headaches, notes Martha S. Lappin, PhD, research director for Energy Medicine Devel opments (North America) in Vancouver, BC. The Canadian company had no intention of using the device for MS patients until a researcher from the University of Washington in Seattle suggested it. "He had a National Institutes of Health grant to study MS. He amended his grant proposal to add a preliminary clinical study to see if MS patients would derive any benefit from pulsed electromagnetic fields," she says.
MS is an unpredictable, chronic, and often disabling disease of the central nervous system that causes inflammation and breakdown in the protective insulation, the myelin sheath, surrounding the nerve fibers of the central nervous system. Recent studies indicate that not just myelin, but nerve fibers, the wire-like connections between nerves and their targets, are damaged and destroyed in regions of the brain affected by MS.
The manner in which MS impedes the conductivity of neurons caused Todd L. Richards, PhD, professor of radiology at the University of Washington in Seattle, to think pulsed electromagnetic fields might be therapeutic for MS patients. "Measurements of the bioelectric patterns of MS patients show they have deficits in certain frequencies. The theory is that if we can supplement those certain frequencies, we can help the brains of MS patients function more effectively," he says.
Narrowing the focus
The first clinical trial in 1996 involved 30 MS patients. The double-blind, placebo-controlled trial found that patients who wore a small device that generated a pulsed electromagnetic field individualized to the patient’s specific needs experienced improvement in many of their MS symptoms, note Lappin and Richards. "Some neurologists criticized the way we measured and analyzed improvements in the first study. The problem is that MS symptoms vary widely from patient to patient. Many physicians and the U.S. Food and Drug Administration [FDA] as well prefer studies that focus on single symptoms rather than on composite scores," Richards says.
Patients in the study experienced improvement in more than one MS symptom, including fatigue, spasticity, and bladder control. MS symptoms are highly individual and vary in severity and duration. They include:
• abnormal fatigue;
• impaired vision;
• loss of balance and muscle coordination;
• slurred speech;
• tremors;
• stiffness;
• bladder and bowel problems;
• difficulties with gait;
• partial or complete paralysis.
The promising results led Energy Medicine Developments to design a second large study and begin the lengthy FDA approval process. The company also shifted its focus from a composite measure to three specific symptoms: bladder control, spasticity, and fatigue. "The FDA is less interested in composite measures than in specific symptoms," says Lappin. "They want you to say this is a treatment for X’ or Y.’
"We were especially interested in fatigue for two reasons," she says." First, fatigue is the symptom most prevalent in all MS patients. Second, fatigue is one of the symptoms the first study showed the most promise to improve. Plus, fatigue often determine whether MS patients can lead full, normal lives and remain employed full-time."
The second study included 119 MS patients treated at three research sites. During the course of the trial, patients were given either an active or inactive device at four-week intervals. "We compared how individual patients rated their fatigue while using Device A, the active device, compared to how they rated their fatigue during their use of Device B, the inactive device," Lappin explains. "Overall, MS patients in the study reported significantly less fatigue while using the pulsed electromagnetic field device than on placebo."
The device used consists of a tiny 3V battery, a coil, and a computer chip programmed to turn the electromagnetic field on and off at certain frequencies. The components are housed in a plastic case. "It was very easy to conduct a double-blind study," notes Lappin. "We simply gave everyone the same plastic case. In some, the wires were connected. In some, they weren’t."
The device delivers brief bursts of weak electromagnetic energy and must be worn close to the skin, she says. "Human beings are very sensitive to the bioelectric fields that occur naturally and are present all around us. The field delivered by the device is weak. Few patients are even aware it. A few are very sensitive and have to start by wearing the device only a few hours a day and gradually step up their wearing time." She says symptoms experienced by individuals sensitive to the magnetic fields include dizziness, headaches, and a disoriented, "foggy" feeling.
The energy bursts are so mild that some patients have to wear the device for several days before they experience a therapeutic effect. The key to the system’s effectiveness is that each device is custom programmed to produce frequencies in which an individual patient is deficient, say Lappin and Richards. "We measure the person’s bioelectric frequencies by placing a sensor over the patient’s head and connecting it to a computer that performs spectrum analysis," Richards explains. "The spectrum analysis shows the individual’s deficits at certain frequencies. The device is programmed to supplement the deficits found in the scan."
To measure the ability of the device to relieve fatigue, researchers used a scale developed by the Consortium of Multiple Sclerosis Centers Services Health Research Subcommittee funded by the National Multiple Sclerosis Society in New York City. (See box, p. 74.)
Results of the second study were presented in March at the 10th Annual Montreux Congress on Stress in Montreux, Swit zerland. Because the study has been submitted for publication, Lappin was unable to share exact data with Case Manage ment Advisor, but she says patients reported "statistically significant" improvement in their fatigue levels while using the device.
The device is approved for use by migraine and MS patients in Canada. Richards uses an Energy Medicine Developments device to control his own migraines. "I haven’t had a migraine headache since September 1997," he says. "I used to suffer from frequent migraines. I also used to experience symptoms of headache, dizziness, and disorientation from working at my computer, and that’s gone now, too," adds Richards, who wears his device several hours each day.
He sees future applications of pulsed electromagnetic field technology for other conditions, such as Parkinson’s and epilepsy. "It takes funding to do the research. However, the applications seem very promising.
"The treatment is noninvasive and has no side effects. We haven’t done long-term studies to measure whether the changes created are permanent, but we don’t think they are," adds Lappin. "This simply means patients must continue to wear the small device every day to experience continued positive effects."
[For more about Energy Medicine Develop ments, visit the company Web site at www.intergate.bc.ca/business/enermed/main.htm or address e-mail to [email protected].
See also: Richards TL, Lappin MS, Acosta-Urquidi J, et al. Double-blind study of pulsing magnetic field effects on multiple sclerosis. J Alternative and Complementary Medicine 1997; 3:21-29. And, Richards TL, Lappin MS, Lawrie FW, Steghauer KC. Bioelectromagnetic applications for multiple sclerosis. Physical Medicine and Rehabilitation Clinics of North America 1998; 9:659-672.]
Modified Fatigue Impact Scale: 5-Item Version
Here is a list of statements that describe how fatigue may affect a person. Fatigue is a feeling of physical tiredness and lack of energy that many people experience from time to time. In medical conditions like multiple sclerosis, feelings of fatigue can occur more often and have a greater impact than usual. Please read each statement carefully, and then circle the one number that best indicates how often fatigue has affected you in this way during the past four weeks. (If you need help in marking your responses, tell the interviewer the number of the best response.) Please answer every question. If you are not sure which answer to select, please choose the one answer that comes closest to describing you. The interviewer can explain any words or phrases that you do not understand.
Because of my fatigue, during the past four weeks. . .
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| 1. I have been less alert. |
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| 2. I have been limited in my ability to do things away from home. |
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| 3. I have had trouble maintaining physical effort for long periods. |
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| 4. I have been less able to complete tasks that require physical effort. |
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| 5. I have had trouble concentrating. |
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Short scale measures fatigue
The five-item fatigue scale is only one assessment tool in a battery of scales called the Multiple Sclerosis Quality of Life Inventory (MSQLI) developed by the Consortium of Multiple Sclerosis Centers Services Health Research Subcommittee funded by the National Multiple Sclerosis Society (NMSS) in New York City.
In addition to the five-item fatigue scale, the MSQLI includes:
• 21-item fatigue scale;
• bladder control scale;
• bowel control scale;
• impact of visual impairment scale;
• perceived deficits questionnaire;
• health status questionnaire (SF-36);
• sexual satisfaction scale;
• pain effects scale;
• mental health inventory;
• modified social support survey.
Each scale in the inventory is validated and reliable. NMSS has agreed to make the inventory and its user’s guide available at no charge to Case Management Advisor readers. To receive the manual, contact NMSS, 733 Third Ave., New York, NY 10017. Phone: (212) 986-3240. Fax: (212) 986-7981. E-mail: [email protected].
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