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Alpha Stim Therapy

The Alpha-Stim® SCS treats anxiety, depression, and/or insomnia with
tiny electrical currents similar to those found naturally in the body, using
a method called cranial electrotherapy stimulation (CES).

The treatment is simple. The current is applied by easy-to-use clip
electrodes that attach to your ear lobes. To control anxiety, depression,
and/or insomnia without drugs in just 20 minutes every other day. Use it
while reading, working at your desk, or watching TV!

What does it feel like?
You may feel a slight tingling sensation under the electrodes, but it is not
necessary to feel this in order to achieve results. Most people feel
nothing at all except positive results.

How can the Alpha-Stim® SCS help?
The Alpha-Stim® SCS empowers you to control your anxiety,
depression, and/or insomnia. Used just 20 to 60 minutes every day,
every other day, or on an as-needed basis, it can help induce a relaxed
state and enable the user to focus attention on the task at hand. The
Alpha-Stim® SCS is well tolerated and very safe in contrast to drugs,
many of which have been proven to have undesirable side effects and
can be addictive.

The Alpha-Stim® SCS leaves the mind alert. The person undergoing
CES treatment will often report a pleasant, relaxed feeling of well-being.
Anxiety reduction is usually experienced during treatment, but may be
seen hours later, or even the day after treatment. Depression and
insomnia control is generally experienced after one to two weeks of daily
treatment.

Maintenance of a relaxed, yet alert state is generally achieved with
treatments three times per week. As a result, the Alpha-Stim® SCS is
suitable for clinical or home use.

What scientific research has been conducted?
At present, there are over 125 research studies on CES in humans and
29 experimental animal studies. The overwhelming majority of the
scientific research is extremely positive. No significant lasting side
effects have been reported.

Harvard University School of Public Health, Department of Health Policy
and Management found: "The meta-analysis of anxiety showed CES to
be significantly more effective than sham (P<.05)." (Meta-analysis of
randomized controlled trials of cranial electrostimulation: efficacy in
treating selected psychological and physiological conditions by Dr.
Sidney Klawansky et al. Journal of Nervous and Mental Disease,
183(7):478-485, 1995.

What are the typical results?
In recent surveys, physicians and patients reported the following results
using Alpha-Stim® CES technology:

Physician Post Marketing Survey of Alpha-Stim® Patients

Condition            N                  Significance greater than 25%
               
Anxiety               349                                94%

Depression     184                                 90%

Stress                259                                93%

Insomnia           135                               79%




Prescribing Information
CE conformity statement for Europe: The Alpha-Stim® SCS is a Class
IIa, Type B medical device. It has been independently tested by outside
agencies in order to provide assurance of conformity to applicable
standards for medical equipment safety and electromagnetic
compliance.
Caution statement for United States: Federal law (USA only) restricts
this device to sale by, or on the order of, a licensed health care
practitioner.
Outside the USA it is available world wide without a
prescription but consultation with a qualified health care professional is
recommended for difficult and unresponsive problems or when used
with pharmaceuticals or other therapeutic intervention.
Indications: Alpha-Stim® cranial electrotherapy stimulation (CES)
technology is continuously being subjected to rigorous study and
evaluation by the international medical community. Findings to date
indicate that the Alpha-Stim® SCS is an effective treatment with broad
applications for a variety of anxiety disorders, or for the short term relief
of the symptoms of anxiety, depression and/or insomnia. In many cases
it is the sole therapeutic method required. As with any therapeutic
intervention, not all people will respond to the Alpha-Stim® SCS. The
degree of efficacy will vary with the nature of the problem being treated
and the overall health of the person.

Contraindications: Alpha-Stim® SCS may affect the operation of
cardiac pacemakers (particularly demand type pacemakers).
Precautions: For external use only. Do not allow children to use or
handle this device without adult supervision. Do not operate potentially
dangerous machinery or vehicles during, and in some cases, for several
hours after treatment. Safety of stimulation has not been established
during pregnancy. There have been isolated reports of blood pressure
being lowered by CES so care should be taken while using the
Alpha-Stim® SCS with high blood pressure medication.
Adverse effects: Adverse effects are usually mild and self-limiting.
Adverse effects seen in approximately 4,541 patients in controlled, open,
uncontrolled conditions, and by physician survey and reasonably
associated with the use of CES are dizziness (6 cases, 0.13%), skin
irritation/electrode burns (5 cases, 0.11%), and headaches (9 cases,
0.20%). Prolonged CES treatment at higher than necessary currents
may cause dizziness or nausea that can last for hours to days.
Treatment immediately prior to going to sleep may cause difficulty
sleeping due to increased alertness. It is recommended that CES be
used at least 3 hours before going to sleep. Paradoxical reactions such
as hyperexcited states, increased anxiety, and sleep disturbances may
occur. If the Alpha-Stim® SCS does not control your anxiety, depression
and/or insomnia within 3 weeks, discontinue use and consult your
physician.

Currently, the Alpha-Stim® SCS is not licensed for sale in Canada.

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