Application of Almag 03 During Cerebral Stroke in Acute Stage

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 5^th-7^th 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 1^st,
2011 and December 6^th, 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:

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:

1. systolic
   BP increase;
2. heart
   rate drop to normal physiological range;
3. increase
   in the blood oxygen saturation level;
4. 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