EN
Comments to
Operating Manual for “ALMAG-03”
Magneto-Therapy Device
Related to Its Application During Cerebral Stroke in Acute Stage
As stipulated by Orders of the Ministry of Health and Social Development of the Russian Federation No.389n dated July 6, 2009 and No.357n dated April 27, 2011, transcranial magneto-therapy shall be applied as part of rehabilitation complex for cerebral stroke, after patient’s transfer from intensive care unit to the unit for patients with acute stroke, starting from the 5th-7th day after the time of disease progression. A magneto-therapy course performed by ALMAG-03 device induces positive reduction of systolic and diastolic blood pressures, heart rate slowing, stabilization of psycho-emotional condition, as well as proper regulation of circadian rhythms. The procedure is prescribed subject to strict observation of the instructions for medical use of “ALMAG-03” Magneto-Therapy Device. Transcranial magneto-therapy procedure shall come as the final stage of rehabilitation complex for cerebral stroke patients, preceded by courses of therapeutic exercising, ergotherapy, logopedic correction and chest massage.
Head of Medical and
Social Rehabilitation Department of
Cerebrovascular Pathology and Stroke Research Institute,
Professor of Rehabilitation and Sports Medicine Chair at
Pirogov Russian National Research Medical University (RNRMU) under
Russian Ministry of Health and Social Development (MoHSD),
Professor and M.D.
G.E. Ivanova
Approved by
Chief Medical Officer of Municipal Clinical Hospital No. 31,
Associate Member of Russian Academy of Medical Sciences,
Professor, Head of Healthcare Management and Sociology Chair at RNRMU named after N.I. Pirogov
under MoHSD of the Russian Federation
G.N. Golukhov
REPORT on
“Application of ALMAG-03 Magneto-Therapy Device During Cerebral Stroke
in Acute Stage”
Rationale
The problem of cerebral stroke is not only of medical, but also of immense social importance, since in many countries stroke is the third leading cause of death and one of the leading causes of disability among middle-aged and elderly people. In Russia, morbidity and mortality rates after stroke are regularly among the highest in the world, with nearly 400,000 strokes registered in the country every year, 70-85% of which are accounted for by ischemic strokes. The probability of a recurrent stroke increases more than nine-fold with patients who have already suffered a stroke or transient ischemic attack. Therefore, stroke prevention is of particular priority among this group of population.
Preventive measures can include both medication and drug-free modalities, one of the latter being exposure to a magnetic field. The positive effect of this therapy is associated with physiological action of magnetic field confirmed by a large record of evidence. The hypotensive, sedative, and regeneration-enhancing properties of magnetic fields are primarily used in medicine, accompanied by their sympatholytic effect on the autonomic nervous system and beneficial effects on microcirculation. The hypotensive effect of magnetic field is attributed to parasympathetic tone increase as well as catecholamine metabolic changes towards an increased level of catecholamine precursors and a decreased level of their terminal metabolites (adrenaline and noradrenaline) in the blood.
In the period between September 1st, 2011 and December 6th, 2011, an assessment study of performance characteristics and effectiveness of the methods specified in the instructions for medical use of ALMAG-03 magneto-therapy device manufactured by Yelatma Instrument Making Enterprise JSC has been conducted at the Cerebrovascular Pathology and Stroke Research Institute of RNRMU named after N.I. Pirogov on the basis of Municipal Clinical Hospital No. 31 under Moscow City Health Department.
The following items have been provided for assessment purposes:
- a pilot sample of ALMAG-03 device (Medical Certification GIKS.941519.106) that has passed the required warranty tests;
- operating manual for ALMAG-03 device (GIKS.941519.106 OM);
- toxicological statement No.9492.011 dd. 14/11/2011;
- draft instructions for medical use.
ALMAG-03 device consists of a control unit and a “headband”-type emitter. The “headband” emitter consists of two flexible emitting lines. Each of the lines contains 6 individual inductors (emitters). ALMAG-03 generates two types of pulsed magnetic field, “travelling” and “static”.
Magnetic field’s effect on 15 patients suffering from cerebral stroke in acute stage has been studied based on device exposure program No.3 applied transcranially for 20 minutes. The device has been used in accordance with the instructions for medical use.
Analysis of data obtained as a result of magneto-therapy course execution.
Changes in blood pressure parameters, heart rate, and blood oxygenation and coagulation profile after a course of magneto-therapy:
| Parameter | Average | Conf. interval (95%) | ||
| Initial course stage | Course end | Initial course stage | Course end | |
| BP (syst., before) | 129.5 | 132.3 | 5.15 | 7.48 |
| BP (syst., after) | 126.5 | 126.7 | 4.85 | 8.46 |
| BP (diast., before) | 82.5 | 78 | 4.19 | 3.91 |
| BP (diast., after) | 79.5 | 76.5 | 4.48 | 4.39 |
| Heart rate before | 67.4 | 68.6 | 4.15 | 6.21 |
| Heart rate after | 66.4 | 68.4 | 5.00 | 5.29 |
| SpO2 before | 94.4 | 94.8 | 1.09 | 0.95 |
| SpO2 after | 95 | 95.8 | 1.04 | 0.70 |
| Prothrombin index (PTI) | 1 | 1.1 | 0.07 | 0.17 |
| aPTT | 30.3 | 32.8 | 2.37 | 2.10 |
before – parameter measured value before magneto-therapy course
after – parameter measured value after magneto-therapy course
While the assessment study has demonstrated no drastic changes in the tested parameters after a course of magneto-therapy, it has nevertheless revealed a trend towards changes of the following indicators:
- systolic BP increase;
- heart rate drop to normal physiological range;
- increase in the blood oxygen saturation level;
- lowering trend of diastolic BP values.
A combination of these changes may indicate normalization of the cardiovascular system regulation. A majority of patients who have undergone a course of magneto-therapy procedures have demonstrated positive improvement in the form of sensory disturbances regression, muscle tone normalization, and build-up of muscle strength in paretic limbs. Patients have noted an improved perception of their well-being, activity and mood (WAM test). Transition from mildly depressed state to normal range has been observed (Zung self-rating depression scale). Reduction of the overall anxiety level has occurred due to stabilization of the health condition (modified Lüscher color test).
Conclusion.
Treatment of patients in the acute period of cerebral stroke with transcranial magneto-therapy procedures by ALMAG-03 device is reasonable and safe in terms of achieving a hypotensive and antianxiety effect, as well as stabilizing the autonomic regulation. ALMAG-03 device can be recommended for use in medical practice for treatment of patients with acute cerebral stroke upon physiotherapist’s prescription and supervision.
Physical Medicine and Rehabilitation Physician
of Neurology Department for Patients with Acute Cerebrovascular Accidents
of Municipal Clinical Hospital No. 31,
Teaching Assistant of Rehabilitation and Sports Medicine Chair at
RNRMU named after N.I. Pirogov,
Candidate of Medical Sciences
A.N.Staritsyn
Head of Neurology Department
for Patients with Acute Cerebrovascular Accidents
of Municipal Clinical Hospital No. 31,
Candidate of Medical Sciences
T.V. Tvorogova