APPROVED BY

Acting Rector of Ryazan State

Medical University

(State Budgetary Educational Institution of Higher

Professional Education)

                               R.E. KALININ

January 24, 2012

RECORDS OF

Medical Trials Performed on ALMAG-03

Magneto-Therapy Device

  1. Medical trials have been performed on the basis of physiotherapy unit of Solotcha Health Resort LLC.
  2. Purpose of the trials: clinical benefit assessment of low-frequency
    magneto-therapy with traveling pulsed magnetic field (PEMF) produced by ALMAG-03 device for treatment of patients with autonomic nervous system disorders (migraines), eye diseases, and Parkinson’s disease.

Migraine is an inherited or acquired vascular disease of the brain. Migraine is characterized by recurring headaches, predominantly in one specific half of the head (also referred to as “hemicrania” – “half of the head”). It usually emerges in adolescent years, more often with females, and lasts for decades, becoming weaker or rarer in the 5th-6th decade of life. Migraine attacks are provoked by emotional stress, insomnia, mental work load, natural conditions (a weather front passing, long-term exposure to direct sunlight, etc.), visual stimuli, alcohol, staying in a stuffy room or sweat bath, etc. Migraine is considered to be a type of vascular (vegetative) neurosis. The underlying basis of migraine clinical pattern is a disturbance of autonomic vascular regulation when blood vessels produce abnormal reactions to normal stimuli. In terms of pathogenesis, migraines with vasospasm or with vasoparalysis are distinguished. There are common, ophthalmic, ophthalmoplegic migraines, migraines with aura, vestibular (migrainous vertigo) and abdominal ones. It was believed for a long time that, despite being extremely painful, migraine does not cause any serious harm to patients’ health. Nowadays, however, migraine is considered to be the most common cause of acute circulatory disturbances of central retinal artery in patients under 30 years of age. This is quite understandable, since migraine attack starts with a vasospasm in the internal carotid artery, when the blood rushes into the external carotid artery (or vice versa), stretches it, and thus causes pain in the corresponding half of the head. In its turn, arterial retinal occlusion is a possible risk factor leading to premature death and shorter life expectancy as compared to patients who do not have any history of such disease. In view of the above, migraines, which affect 4 to 20% of population (or even more) according to different estimates, can be considered quite an important disease area. Therefore, a search for different methods of its treatment is required, which is why the present research has been conducted. Traditionally, physical factors of an essentially “distracting” nature are used for treatment and prophylaxis of migraines. For purposes of this research, transcranial magneto-therapy with ALMAG-03 device manufactured by Yelatma Instrument Making Enterprise JSC has been applied. To conduct the research, the following items have been provided:

ALMAG-03 device (GIKS.941519.106), factory serial No.00003, which has passed the required warranty tests;

Operating Manual for ALMAG-03 device;

Draft instructions for medical use;

TVGD-01 IOP tonometer (1 pc.);

Operating Manual for TVGD-01 device.

Treatment has been carried out in accordance with the instructions for medical use.

Magneto-therapy with ALMAG-03 device has been applied on 14 patients (all female) suffering from migraines. 11 of them were diagnosed with a common form of migraine (without aura), 3 with ophthalmic (“classic”) migraine with visual aura. All patients were provided with basic anti-migraine therapy. 7 patients in the out-of-attack phase showed signs of vegetative dystonia (transient mild increase in blood pressure, resistant red dermographism, dystonia of eyeground vessels, hyperreflexia); 9 patients had sleep disorders and meteorolability; 6 of them demonstrated correlation of attacks with the menstrual cycle phase. 12 patients noted signs of asthenia: irritable weakness, mood swings, “neither healthy – nor sick” sensation; they also had headaches in the period between the attacks, which, however, did not reach the intensity of a full migraine attack. 3 patients experienced frequent migraine attacks (at least once a week).

During treatment, the patients’ complaints were taken into account (to achieve result objectivity, Migraine Questionnaire was used), as well as their BP levels, pulse oximetry data, 100-mm visual analogue scale of pain, and Spielberger-Hanin scale for anxiety level self-assessment. All patients had their ECG recorded and heart rate variability measured. They were also examined by a neurologist and had direct ophthalmoscopy (with Riester ophthalmoscope) performed on them; 6 of the patients were tested for INR, prothrombin index, aPTT, fibrinogen.

Program No.4 has been used for all patients, with the emitters placed at the forehead level: a total of 10 procedures for each patient have been given with a two-day break. Procedure tolerability was good with 13 patients, while one of them experienced short-term non-rotary vertigo which did not require discontinuation of treatment. All patients have received a full course of magneto-therapy.

The following results were obtained: 12 patients have noted a subjective improvement of their health condition (85.7%); headache has completely subsided in 9 patients (64.2%); normal values of blood pressure have been registered in 10 patients (71.4%). Ocular fundus condition was within normal range for 12 patients (85.7%). State and trait anxiety parameters: high level of anxiety (within 55±3.8) had been demonstrated by 10 patients before treatment start, the rest of them had showed anxiety level within 40±1.4; anxiety level after treatment was within 41±2.7 (moderate anxiety). Pulse oximetry (SpO2): before treatment, it was in the range of 95±1.2 with 10 patients, after treatment – 97±1.1. Blood clotting parameters measured for 6 patients were originally within normal limits.

Headaches (in the out-of-attack phase) were evaluated by patients within 6±1.2 before, and 4±1.8 after treatment. Sleep quality improvement was reported (subjectively) by 8 patients (57.1%). When heart rate variability was measured, the average value (regulatory processes adequacy index) was within 6±1.9 before and 3±1.6 after treatment (note: improvement was registered at the sympathetic level of cardiovascular system regulation). Based on neurologist’s examination, clinical improvement was observed in 6 patients (42.8%). Unfortunately, prospective follow-up for the subsequent four weeks could only be traced for 3 patients (who did not have migraine attacks during that period). But a preliminary conclusion can still be made: the use of low-intensity transcerebral magneto-therapy with a travelling field can significantly improve the condition of such patients and the “quality” of their attack-free periods. Regarding the question whether magneto-therapy is able to prevent progression of migraine attacks: further research needs to be conducted, since 3 of the patients had recurrent attacks after 2, 3 and 5 procedures of magneto-therapy. The patients, however, described those attacks as “non-typical” (the pain was weaker and the duration of attacks was 2 – 2.5 hours shorter than usual).

The research findings suggest that magneto-therapy is an effective method of migraine treatment (primarily of preventive nature).

The second part of the study focused on the use of magneto-therapy with a traveling field for treatment of eye diseases. The problem of impaired vision and eye diseases remains to be quite urgent. According to data from 2006, the number of blind people and people with serious visual impairments in Russia was about 300,000. As long as the number of patients with coronary artery disease, atherosclerosis, diabetes, and eye diseases as such, is growing, the number of visually impaired people and people who are irreversibly losing their sight increases accordingly. Sharp visual deterioration, not to mention congenital or acquired blindness, are very serious conditions. Therefore, any treatment method aimed at inhibiting deterioration of eyesight, or improving it, needs to be considered very carefully.

Magneto-therapy with ALMAG-03 device has been applied on patients suffering from the following conditions:

In the treatment process, the patients’ complaints were taken into account, as well as data of direct ophthalmoscopy (including that done on dilated pupils) and biomicroscopy, visual field, visual acuity, and color vision tests, IOP measurements, BP levels, data of pulse oximetry and anxiety level self-assessment as per Spielberger-Hanin scale. All patients had their ECG recorded and heart rate variability measured. They were also examined by an ophthalmologist and had direct ophthalmoscopy (with Riester ophthalmoscope) performed on them; 19 of the patients were tested for INR, prothrombin index, aPTT, fibrinogen. Patients with diabetic retinopathy were tested for blood glucose level twice. Exposure program No.3 has been used on patients with primary choroidal dystrophy, diabetic retinopathy, age-related macular degeneration, and after-effects of thrombosis of central retinal vein branches. For patients with glaucoma, chronic iridocyclitis, and cataract, Program No.2 has been applied. Procedures on patients’ eyes have been done through closed eyelids. A lot of patients with vitreoretinal dystrophy (66.6%), primary open angle glaucoma (80%), and age-related macular degeneration (50%) have reported subjective improvement of vision after 5-7 sessions of magneto-therapy, and sustained improvement after course completion. Their average visual acuity before treatment was 0.66±0.05 D, after treatment – 0.78±0.02 D.

With glaucoma patients, their IOP before treatment was in the range of 24.5±0.5, after treatment – 22.3±0.3 mmHg (as measured with TVGD-01 tonometer). In case of patients with diabetic retinopathy, after-effects of thrombosis of central retinal vein branches, and cataract, their visual acuity after magneto-therapy (average original visual acuity = 0.4±0.06 D without correction) has not changed. At the same time, there were changes in the IOP of 66.6% of patients with phacogenic glaucoma: their initial IOP was 23.5±0.4 mmHg, while after treatment it dropped to 21.4±0.6 mmHg.

Ophthalmoscopy has revealed improvement of ocular tension parameters in 43.5% of patients with choroidal dystrophy and 51.2% of patients with age-related macular degeneration. Patients with diabetic retinopathy were compensated for diabetes; however, no significant changes in IOP or ocular tension have been noted. Chronic uveitis (iridocyclitis) has proved to be the most unresponsive to exposure among these diseases. Magneto-therapy has failed to produce any effect on its course. 96.3% of patients had registered high levels of anxiety on Spielberger-Hanin scale (above 50%). After the treatment, it has lowered to the average level of 41.5±2.3 with just 36.7% of patients, while remaining at the high level with the rest. Pulse oximetry has shown no significant deviations from the norm. When heart rate variability was measured, the original value (regulatory processes adequacy index) was within 6.3±1.2 before treatment and reduced to 5.4±0.9 afterwards, but it still did not reach the normal range at course end. In this regard, considering the positive tendencies and after-effect of the magnetic field action, a repeated treatment course is recommended in 1.5 – 2 months.

Eye disorders prove to be a very important concern for patients, causing a lot of stress and agitation at the sympathetic level of regulation. The research findings allow us to recommend inclusion of transorbital magneto-therapy into course treatment of glaucoma, age-related macular degeneration and vitreoretinal dystrophy.

The third part of the study was devoted to assessment of magnetic field’s clinical effectiveness for cases of Parkinson’s disease. Parkinsonism is a set of symptoms characteristic of various central nervous system diseases, whose major clinical manifestations include rigidity, or plastic muscular hypertonia, and oligobradykinesia (deficiency and slowness of movement, lack of facial expressions) which can sometimes reach the degree of total immobility. These symptoms cause patients to lose their self-care ability, which leads to significant deterioration of their quality of life. Searching for new methods of dealing with parkinsonism symptoms is crucial because the existing antiparkinsonian drugs have multiple side effects, and the prevalence of Parkinson’s disease is very high (300 to 1800 cases per 100,000 of population aged 50 years and above).

Transcerebral magneto-therapy has been applied on 10 Parkinsonian patients (4 of whom have primary parkinsonism (Parkinson’s disease) and 6 have vascular parkinsonism (affected by vascular encephalopathy). All patients had been diagnosed with akinetic-rigid and tremor-dominant Parkinson’s disease; two of them were at stage 2, four at stage 1. The patients were consulted by a neurologist twice; direct ophthalmoscopy and pulse oximetry were performed, their ECGs recorded (heart rate variability measurements were false due to the tremor). Patients received basic antiparkinsonian therapy (selegiline and amantadine), massage, individual therapeutic exercises with a physiologist, and magneto-therapy sessions by ALMAG-03 device.

Reduction of muscular hypertonia has been observed in 1 patient with primary parkinsonism and all patients with symptomatic parkinsonism after 5-6 procedures. After 10 completed procedures, objective reduction of muscular hypertonia has been noted in all patients, and this effect has stayed for 5-6 days afterwards.

Based on the above data, transcerebral magneto-therapy can be considered appropriate for antiparkinsonian application for purposes of slowing down the disease progression (especially that of vascular origin), improving the patients’ quality of life, reducing muscle rigidity, improving cerebral blood supply and, ultimately, improving the functional capacities of patients with Parkinson’s disease.

Vice-Rector for Academic Affairs of

Ryazan State Medical University

(State Budgetary Educational Institution

of Higher Professional Education under

MoHSD of Russia),

Professor, M.D.

Y.Y. Byalovsky

Chief Medical Officer of

Solotcha Health Resort LLC,

High-Level Certified Physician,

Candidate of Medical Sciences

N.E. Larinsky

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