Phys Med Rehabil Clin N Am 1998 Aug;9(3):659-74

Department of Radiology, University of Washington, Seattle, USA.

Phys Med Rehabil Clin N Am 1999 Aug;10(3):729-54

Department of Family and Community Medicine, Baylor College of Medicine, Houston, Texas, USA.

J Altern Complement Med 1997 Spring;3(1):21-9

Published erratum appears in J Altern Complement Med 1997 Summer;3(2):205

,In Biologic Effects of Light 1998 Symposium, Eds Holick MF, Jung EG, Kluwer Academic Publishers: Boston, pg. 337-342, 1999

Richards TL, Acosta-Urquidi, J

TL Richards, PhD, University of Washington, Radiology Department

The primary purpose of this research was to test the effects of a pulsing electromagnetic field on the symptoms and quality of life experienced by individuals suffering from multiple sclerosis (MS). This project used the Enermed device (Energy Medicine Developments (North America), Inc.) to expose patients to individually programmed pulsed electromagnetic fields. Previous results using this device have been reported for both multiple sclerosis (1) and migraine patients (2). We have recently published a review of bioelectromagnetic applications for multiple sclerosis (3) and this document contains background information on bioelectromagnetism and possible mechanisms for biological effects. Weak electromagnetic fields have been shown to affect nerve regeneration, brain electrical activity (electroencephalography), neurochemistry, and immune system components (see reference 3 and citations therein).

The effectiveness of the treatment was assessed in a 10 week, randomized, placebo-controlled, double-blind crossover study. Data were collected from three sites: University of Washington, Seattle, WA; Cooper Health System/Robert Wood Johnson Medical School, Camden, NJ; Neurology Center of Fairfax, Virginia. Subjects came on site for 4 visits for evaluation before and after exposure to both active (Enermed) and inactive (Placebo) devices. This study was reviewed and approved by the Institutional Review Board/ Human Subjects Committee at each site.

MS patients were recruited from all three sites (125 total completed the study). To meet inclusion criteria subjects were: 1) diagnosed with clinically definite MS (Poser criteria); 2) between the ages of 18 to 60 inclusive; 3) medically stable -- no MS exacerbations for two months prior to the study; 4) medicinally stable - no changes in prescription for one month prior; 5) disabled in bladder control or muscle spasticity with a symptom rating of 2 or higher (0 = no symptoms, 5 = severe symptoms).

Subjects were exposed to a pulsing magnetic field produced by the Enermed device. This device is a watch-sized, programmable magnet powered by a 3 volt battery. It is designed to be worn close to the body, and produces a 1 millisecond magnetic pulse in the 50 to 100 milliGauss range. A programmable chip allows the magnetic pulse trains to be sequentially produced for one to 16 frequencies (12.7 seconds duration for each frequency). In order to determine the most appropriate frequencies for treatment, each patient was scanned with a Bioelectric Frequency Analyzer (BFA) which measures weak electromagnetic fields produced by the body. The BFA consists of a quartz crystal detector embedded in a padded headset. The output signal is linked to an amplifier and a small computer for spectrum analysis. After subjects' devices were programmed they were shown how to tape or attach the device to a spot just below the collar bone on the chest. They were instructed to wear the device 6 hours the first day and then increase wearing time by 2 hours each day up to 24 hours a day.

The primary outcomes of this study were daily diary measures of bladder control and muscle spasticity. These included reports of daytime and nighttime urination frequency and ratings of the severity of any spasticity experienced during the day and night. Daily reports for the last three weeks of each treatment session (Enermed and Placebo) were averaged and compared. Secondary outcomes consisted of symptom ratings scales from the MS Quality of Life Inventory (MSQLI) developed by the Health Services Research Subcommittee of the Consortium of Multiple Sclerosis Centers (4). We used four of the abbreviated MSQLI scales (bladder control, fatigue, perceived deficits, and pain/sensory problems), plus a spasticity scale we created by modifying the pain effects scale. The surveys were administered prior to the first treatment session (baseline measure), and immediately following each four week treatment session. All five scales had excellent internal consistency reliabilities with Cronbach alphas averaging .80 or higher across the three time periods.

The daily diary measures were analyzed using repeated measures ANOVA, both with and without adjusting for covariates (age, sex, ability to walk 10 yards unassisted, and treatment sequence). Neither analysis showed significant treatment effects on frequency of urination or daily spasticity ratings.

Survey Data

Sample Selection. Before analyzing the survey data we dropped the 5 subjects who had physician diagnosed exacerbations during the course of the study and the 14 subjects who reported at baseline that they had no problems ("0") with spasticity and bladder control. This allowed us to examine the data for the subset of subjects (n=105) who might truly be candidates for the therapy, i.e., those experiencing relevant symptoms, without the error variance introduced by exacerbations and steroid treatments.

Spasticity and Bladder Control Problems. The means on the spasticity and bladder control scales favored the Enermed group, but were not statistically significant.

Fatigue, Pain, and Cognitive Problems. Next we looked at the remaining three MSQLI scales: fatigue, pain/sensory effects, and perceived cognitive deficits. We were especially interested in fatigue, as this symptom showed the greatest improvement within the Enermed group in our first study (1). Paired t-test results showed a significant treatment effect for fatigue (t=-2.59, p<.01), but not for the other two symptoms (Pain t=-1.30, p<.20; Cogntive t=-.66, p<.51) . To rule out the possibility that the observed effects for fatigue were due to one or two extreme scores in the negative tail of the distribution, we also conducted a non-parametric test (Wilcoxon Signed Ranks test), based on ranks instead of means. This test also showed a significant treatment effect. In fact, ranks from the Wilcoxon test indicate that the ratio of subjects showing improvement on the Enermed relative to the placebo device was about 1.6 to 1.0 (56:36 with 12 ties). In other words, for every 10 subjects showing greater placebo effects , 16 subjects showed greater improvements on the Enermed device. 

Subgroup Analyses. To see if certain subgroups responded differently to the Enermed we used repeated measures ANOVA to examine fatigue as a function of a) years with MS, b) ability to walk 10 yards, c) severity of symptoms at baseline, d) type of MS, e) sex, and f) research site. None of the interactions was significant, however, there were some trends worth noting.. The Enermed appears to be most effective at alleviating fatigue for MS patients who can walk 10 yards unassisted and whose symptoms are neither very mild nor very extreme (see Figures 3 and 4). There were also unexpected significant main effects for research site - overall changes were greater at the Fairfax site than the New Jersey site, although the treatment effects appear proportional at the two sites (see Figure 5). Possible reasons for these differences need to be explored further.

Although the primary outcome measures (dairy reports) did not show significant treatment effects, the results of our secondary, survey-based analyses were encouraging. The MSQLI fatigue scale showed a significant treatment effect, and post-hoc analyses showed this result was replicated in one of the two single item measures of fatigue included in other instruments. These results clearly warrant additional research with a primary focus on fatigue. Fatigue is one of the most debilitating symptoms associated with MS, and any non-invasive, non-pharmacological therapy that might alleviate its effects would be a tremendous addition to the therapies currently available to MS patients.

1. Richards TL, Lappin MS, Acosta-Urquidi J, Kraft GH, Heide AC, Lawrie FW, Merrill TE, Melton GB, Cunningham CA, Double-blind study of pulsing magnetic field effects on multiple sclerosis. J Altern Complement Med 3:21, 1997.

2. Lappin MS, Research on the utility of medigen device as a treatment for migraines. Research Report #1, April 1995. Vancouver, B. C.: Energy Medicine Developments (North America) Inc.

3. Richards TL, Lappin MS, Lawrie FW, Stegbauer KC, Bioelectromagnetic applications for multiple sclerosis, Physical Medicine and Rehabilitation Clinics of North America, 9, 659-674, 1998.

4. Ritvo PG, Fischer JS, Miller DM, Andrews H, Paty DW, LaRocca NG, Multiple Sclerosis Quality of Life Inventory: A User's Manual. New York: National Multiple Sclerosis Society, 1997.

We thank the Multiple Sclerosis Association of America for their generous financial support. We also thank Dr. Richard Kronmall and Statistics and Epidemiology Researach Corporation for help with statistics and data analysis. We acknowledge the help of Catherine Cunningham for recruitment of subjects. 

Figure 1 is a real Enermed Device. - placed next to methods

Figure 2 is a diagram of placement of Enermed Device on the body.

Figure 3 - placed below results section