For Anxiety For DepressionFor Insomnia Alpha-Stim®
LET NOTHING STOP THEM.™
Alpha-Stim® AId
LET NOTHING STOP THEM.™
Relieve your patients’ symptoms of anxiety, depression, and insomnia,
quickly and safely, with Alpha-Stim®.
The Alpha-Stim AID is a Cranial Electrotherapy Stimulation* (CES) device that
uses low-level electrical current to safely and effectively treat anxiety,
depression, and insomnia.
• Alpha-Stim treatments are cumulative; however,
most patients show at least some improvement
after the first treatment.
• Alpha-Stim technology is safe, with no serious
adverse events reported in over 30 years of
clinical use.
• Alpha-Stim devices can be used as a first-line
therapy or as an adjunct to pharmacotherapy
(without polypharmacy effects).
* Initially cleared for marketing by the FDA in 1992 as a prescriptive, noninvasive treatment, Alpha-Stim has an extensive safety record,
with few side effects (less than 1%) and considerable scientific evidence of the significant results patients can achieve.
THE FOuNdATION: A Patented Waveform• Effectively targets cell receptors, activating them through frequency matching in a manner similar
to chemical ligands
• Delivers a very low level of current in pulsed microcurrents of less than one milliampere
• Provides a wide range of biological frequencies that no other device can emulate
• The only rigorously tested waveform designed and refined to improve effectiveness
THE IMPAcT: An Electrical Intervention• The brain functions electrochemically and can be readily modulated by electrical intervention1,2
• Alpha-Stim impacts the electrochemical function of the brain to improve patients’ emotional
and physiologic states
– Designed to affect the activity of subcortical brain structures known to regulate emotions
– fMRI studies demonstrate the waveform current changes the appropriate brain structures
THE rESuLTS: Significant Improvement, Quickly, with Lasting Effect
There is an increase (red) in alpha activity with a simultaneous decrease (blue) in beta and delta.2
qEEG changes in 30 subjects treated with 20 minutes of Alpha-Stim CES.
As the leader in CES, Alpha-Stim has helped clinicians around the world offer fast, safe, and effective relief for patients suffering from anxiety,
depression, and insomnia.
After 5 weeks of treatment, the active Alpha-Stim CES group reported an average
decrease of 94% in their anxiety3
Alpha-Stim CES recipients demonstrated an average increase of 43 total minutes of sleep time
after only 5 treatments**6
By tracking the anxiety levels of patients over 6 months, Alpha-Stim was reported to reduce feelings
of anxiety by an average of 76%4
Alpha-Stim CES reduced patient sleep disturbances, completing this 8-week study
with scores below the range of insomnia**7
In a study of preoperative anxiety, Alpha-Stim recipients reported significantly less anxiety after
one 20 minute application5
Alpha-Stim CES recipients reported a 36% improvement in quality of sleep
compared to sham recipients**8
PrOVEN: Alpha-Stim Significantly Reduces Anxiety Symptoms
PrOVEN: Alpha-Stim Significantly Reduces Insomnia
**Insomnia reduction varies widely, with some individuals having improved sleep immediately and others not having improved sleep until weeks into treatment.
10
20
30
40
50
60
70
GENERAL ANXIETY SCORES
Anxiety Patients, NRS, 5 Weeks, N=197Psychological Services in Chambersburg, PA
p<0.0562.3
14.8BASELINE ENDPOINT
Mea
n An
xiet
y Sc
ores
General Anxiety Disorder, HAM-A, 5 Weeks, N=108Liberty and Stetson Universities
Mea
n An
xiet
y Sc
ores
10
15
20
25
30
BASELINE WEEK 1 WEEK 3 WEEK 5
29.5
27.6
19.9
22
16.1
19.9
13.4*
20
*p=0.001 d=0.94
ANXIETY SCORES OVER 5 WEEKS
Active Sham
PREOPERATIVE ANXIETY SCORES
Preoperative Anxiety, Post Alpha-Stim CES Treatment
Mea
n An
xiet
y Sc
ores
1.24*
2.76
0.0
.5
1
1.5
2
2.5
3
SHAMCES
*p= 0.016
Likert Scale, 2 Treatments, N=50Korea University College of Medicine
CHANGE IN TOTAL SLEEP TIME
Service Members, Sleep Log, After 5 treatments, 5 Days, N=57Walter Reed National Military Medical Center
Chan
ge in
Tot
al S
leep
Tim
e
43
-19
-30
-20
-10
0
10
20
30
40
50
SHAM
CES
Day 1: p=0.04 d=0.41Day 4: p=0.03 d=0.49Day 5: p=0.079
IMPROVED SLEEP QUALITY
SHAMACTIVEEndpoint of Study
Adju
sted
Mea
ns S
leep
Qua
lity 5.2*
3.3
*p=0.02
0
1
2
3
4
5
6
Chronic Pain Patients, NRS, 3 Weeks, N=60Robert Wood Johnson Medical Center
IMPROVEMENT IN SLEEP DISTURBANCE
WEEKS
Gene
ral S
leep
Dis
turb
ance
Sca
le
0
1.00
2.00
3.00
4.00
5.00
6.00
0 2 4 6 8
Active Sham Usual Care
p=0.001
Chronic Pain Patients, Sleep Disturbance, 8 Weeks, N=46University of Virginia
After 5 weeks of treatment, the active Alpha-Stim CES group reported an average
decrease of 75% in their depression3
After only 5 days of therapy with Alpha-Stim, the effective rate was 94%10
After 6 weeks of treatment, Alpha-Stim users experienced a 42.8% improvement9
After 3 weeks of treatment with Alpha-Stim, active (but not sham) participants achieved significant
improvement in depressive symptoms11
PrOVEN: Alpha-Stim Significantly Reduces Depression Symptoms
The proprietary Alpha-Stim waveform is supported by more scientific research than any therapeutic medical device in its class. For additional clinical research, contact your Alpha-Stim representative.
LET NOTHING STOP THEM.™
HELP FOr yOur PATIENTS SuFFErING FrOM ANxIETy, dEPrESSION, ANd INSOMNIA IS HErE.
Getting started with Alpha-Stim
To offer Alpha-Stim to your
patients, contact your
Alpha-Stim representative
or visit Alpha-Stim.com.
We offer free trials to licensed
practitioners. Typically, an in office or
clinic trial can identify those individuals
who readily respond to treatment.
Ordering through Alpha-Stim.com
is easier than ever. You or your
patients can fulfill your order for
Alpha-Stim through our online store,
through your local authorized Alpha-Stim
representative, or by calling our customer
service center.
Alpha-Stim is ideal for clinical or home
use. Safe and easy to use in the office
or at home, Alpha-Stim is cost-effective
compared with drugs and other devices
used to treat similar symptoms.
3 WEEK DEPRESSION TREATMENT
Mea
n D
epre
ssio
n Sc
ores
*p<0.001
PRE POST
49.6
34.1*
47.2 46.8
30
35
40
45
50
55
Active Sham
Children with Depression, Zung Depression Scale, 3 Weeks, N=60 ChildrenNanjing Medical University
MIXED ANXIETY AND DEPRESSION DISORDER
p<0.010.64
0.52
PRE POST0.50
0.55
0.60
0.65
Mea
n D
epre
ssio
n Sc
ores
Mixed Anxiety and Depression Disorder, Zung Depression Scale, 3-15 Treatments, N=32 ChildrenBeijing Children’s Hospital
IMPROVEMENT IN DEPRESSION
6789
101112131415
WEEK 5WEEK 3WEEK 1BASELINE
Depression Patients, HAM-D17, 5 Weeks, N=108Liberty and Stetson Universities
Dep
ress
ion
Mea
n Im
prov
emen
t 14.5
13.2
9.6
10.2
8.1
9.9
6.5*
10
*p=0.001 d=0.75
Active Sham
REDUCED DEPRESSION SCORES
10.5
65
6
7
8
9
10
11
ENDPOINTBASELINE
Depression Patients, HAM-D17, 6 Weeks, N=12University of California at Los Angeles
Mea
n D
epre
ssio
n Sc
ores
p=0.01 d=0.41
Electromedical Products International, Inc. (EPI) was founded in 1981 by Dr. Daniel L. Kirsch, a world-renowned neurobiologist, who developed a safe and effective solution for the treatment of pain, sleep, and mood disorders with Alpha-Stim technology. He was the recipient of the 2008 prestigious Richard S. Weiner Pain Educator of the Year Award from the American Academy of Pain Management. EPI was a recipient of the 2013 Best of Business Award in the Surgical and Medical Instruments category by the Small Business Commerce Association (SBCA), and holds multiple patents. Today, EPI is a global enterprise with representatives throughout the world, with staff dedicated to the pursuit of excellence in the treatment and diagnosis of medical and healthcare-related issues.
EPI is a FDA registered establishment with operations certified by an independent third party to the International Standards Organization (ISO) 13485:2003 standards for quality in medical devices. Alpha-Stim products earned and maintain the CE mark through the European Medical Device Directive and are FDA-cleared for marketing.
AbOuT ELEcTrOMEdIcAL PrOducTS INTErNATIONAL, INc: A Dedicated Company You Can Trust
For Anxiety
Manufactured and marketed by:
Electromedical Products International, Inc. 2201 Garrett Morris Parkway • Mineral Wells, TX • 76067-9034 • USA
1-800-FOR-PAIN (367-7246) in USA
Tel: + (940) 328-0788 (Outside USA) • Fax: (940) 328-0888
www.Alpha-Stim.com
Authorized Representative for the European Union: MediMark Europe11, rue Émile Zola – BP 2332/38033 Grenoble Cedex2– FranceTél: +33 (0)4 76 86 43 22 / Fax: +33 (0)4 76 17 19 82E-Mail: [email protected]
Alpha-Stim and the Alpha-Stim logo are registered trademarks, and LET NOTHING STOP THEM is a trademark of Electromedical Products International, Inc. © 2017 Electromedical Products International, Inc. All rights reserved. Manufactured under US Patents 8,612,008 and 8,457,765.
REFERENCES1. Heffernan M. Comparative effects of microcurrent stimulation on EEG spectrum and correlation dimension. Integrative Physiological and Behavioral Science. 1996;31(3):202-209.
2. Kennerly R. Changes in quantitative EEG and low resolution tomography following cranial electrotherapy stimulation. PhD Dissertation, the University of North Texas. 2006;529 pp., 81 tables, 233 figures, 171 references.
3. Barclay TH, Barclay RD. A clinical Trial of cranial electrotherapy stimulation for anxiety and comorbid depression. Journal of Affective Disorders. 2014;164:171-177. Presented at the American Psychological Association National Conference, Honolulu, July 2013.
4. Overcash SJ. Cranial electrotherapy stimulation in patients suffering from acute anxiety disorders. American Journal of Electromedicine. 1999;16(1):49-51.
5. Lee SH, Kim, WY, Lee CH, et al. Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. Journal of International Medical Research. 2013;41(6) 1788-1795.
6. Lande RG, Gragnani C. Efficacy of cranial electric stimulation for the treatment of insomnia: A randomized pilot study. Complementary Therapies in Medicine. 2013;21(1):8-13.
7. Taylor AG, Anderson JG, Riedel SL, et al. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Management Nursing. 2013;Dec;14(4):327-35.
8. Lichtbroun AS, Raicer MMC, Smith RB. The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology. 2001;7(2):72-78.
9. Bystritsky A, Kerwin L, Feusner J. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder. Journal of Clinical Psychiatry. 2008;69:412-417. Presented at the American Psychiatric Association meeting, San Fransicso, 2009.
10. Lu XY, Wang AH, Li Y, et al. Safety and effectiveness of cranial electrotherapy stimulation in treating children with emotional disorders. Chinese Journal of Clinical Rehabilitation. 2005;9(8):96-7.
11. Chen Y, Yu L, Zhang J, et al Results of cranial electrotherapy stimulation to children with mixed anxiety and depressive disorder. Shanghai Archives of Psychiatry. 2007;19(4):203-205.
Alpha-Stim M
Alpha-Stim AID
REV D
Type B Equipment. This stimulatoris internallypowered only.
See instructions for use. Read the manual thoroughly before using.
Electr
omedi
cal Products International, Inc.
ISO 13485:2003 A28461
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