Transcript Slide 1

Cranial Electrical Stimulation
(CES)
Cynthia T. Gragnani, Ph.D
Walter Reed Army Medical Center
October 25, 2010
Electricity In Medicine
• 1868 Judah Moses- “Galvanic Spectacles”
• 1910 Emil Du Bois-Reymond- “Electrotonus”
• Present Day-Cardiac Pacemakers, Velocity Tests,
Electrotherapy Devices
What is Cranial Electrical Stimulation
• Cranial Electrical Stimulation (CES) was
established in 1981 as a Class II, Type B
medical device regulated and approved by the
Food and Drug Administration
• CES using mild micro current levels of electrical
stimulation applied across the head via
transcutaneous electrodes applied to the
earlobes
• CES can be used to treat a variety of symptoms
including; anxiety and insomnia
How does Alpha-Stim Work
Legend:
Blue arrows: inhibitory interactions
Purple arrows: excitatory interactions
Yellow X: suppressed pathways/interactions
Reference: Kirsch, Daniel L. Cranial electrotherapy stimulation for the treatment of anxiety, depression, insomnia and other
conditions. Insert: Giordano, James. Illustrating how CES works. Natural Medicine, 23:118-120, 2006.
Method of Use
Wet the clips with
the conductive
solution, and attach
them to your
earlobes
Press the left-hand
button to switch on, and
press the right-hand
button to select 20 or 60
minutes
Adjust the intensity
of the stimulation
using the dial on the
side
Image Courtesy of: Electromedical Products International, Inc. (http://www.alpha-stim.com/SCS.html)
Treatment Protocol
• CES 20 minutes to an hour daily for 1-2
weeks
• Followed by a reduced schedule of 2-3 CES
treatments a week until the symptoms are
resolved
• Use on a as needed basis thereafter
Side Effects & Contraindications
Side Effects:
• Dizziness (6 cases or 0.13%), headaches (9 cases or
0.20%) and skin irritation (5 cases or 0.11%) seen in
approximately 4,541 patients using CES
Contraindications:
• Pregnancy
• Cardiac pacemakers (particularly demand type
pacemakers)
• Vertigo
• Caution with those taking high blood pressure medication
• Operating potentially dangerous machinery/vehicles
• Use immediately prior to going to sleep
The Scientific Research
• Most researched medical device in its class
• Over 125 research studies in humans and 29
experimental animal studies
• No significant lasting side effects have been
reported in over two decades of use
The Scientific Research (cont.)
Reference: CES In The Treatment of Insomnia: A review and Meta-Analysis, by
Dr. Daniel L. Kirsch & Marshall F. Gilula. Practical Pain Management, 2007.
The Scientific Research (cont.)
Reference: Incorporating Complementary and Alternative Medicine Therapies
to Expand Psychological Services to Veterans Suffering From
Chronic Pain, by Gabriel Tan et al., Psychological Services, 2010.
Current Study at Walter Reed
Army Medical Center
• Efficacy of Cranial Electrical Stimulation for the treatment of
insomnia
• Active duty military service members at Walter Reed Army
Medical Center
• Screening measures: Pittsburgh Insomnia Rating Scale and
the Zung Depression Scale
• Recruiting 40 subjects
• Double-blind, random assignment (functional or nonfunctional
condition)
• 5 consecutive days of tx
• Pre, Mid, & Post Assessment Measures
Outcome Variables
Primary Outcome Variables:
• Time to sleep, total sleep time, and number of awakenings
Secondary Outcome Variables:
• Pittsburgh Insomnia Rating Scale-20
• Pre-Sleep Arousal Scale
• Epworth Sleepiness Scale
Assessment Measure Schedule
Assessment Measures
Sleep Log
PIRS-20
Epworth Sleepiness Scale
Prior to Day 1 Day 2 Day 3 Day 4 Day 5 3 Days 10 Days
TX
(TX)
(TX) (TX) (TX) (TX) Post-TX Post-TX
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
No
Demographic Questionnaire
Pre-Sleep Arousal Scale
Active/Inactive Device
Yes
No
Preliminary Findings
• Data collection began in March 2010
• Preliminary Descriptive Data:
o
o
o
o
o
Data collected on 18 subjects
13 Males and 5 females
The majority of the subjects were in the 21-25 age
range (e.g. 33%)
Most popular method of treating sleep aliments:
Medication (e.g. 50%)
Average initial PIRS score: between 21-39 (e.g. 79%)
Scores can range from 0-60. A score of 21 & above
indicates a primary diagnosis of insomnia
Clinical Use of CES
•
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Introduction
Training
Acceptance
Recruitment
Pros
Clinical Findings
Insomnia: CES Research References
•
Kirsch, Daniel L. and Gilula, Marshall. CES in the treatment of insomnia: A review and metaanalysis. Practical Pain Management, 7(7):28-39, 2007 .
•
Kirsch, Daniel L. Cranial electrotherapy stimulation for the treatment of anxiety, depression,
insomnia and other conditions. Insert: Giordano, James. Illustrating how CES works. Natural
Medicine, 23:118-120, 2006.
•
Gilula, Marshall F. and Barach, Paul R. Cranial electrotherapy stimulation: a safe neuromedical
treatment for anxiety, depression, or insomnia Southern Medical Journal. 97(12):1269-1270,
2004.
•
Kirsch, Daniel, L. and Smith R.Cranial electrotherapy stimulation for anxiety, depression, insomnia
cognitive dysfunction, and pain. In Bioelectromagnetic Medicine. Paul J. Rosch, Ed. Marcel Dekker,
New York, Pp 727-740, 2004.
•
Kennerly, Richard. QEEG analysis of cranial electrotherapy: a pilot study. Journal of Neurotherapy
(8)2, 2004. Presented at the International Society for Neuronal Regulation annual conference,
September 18-21, 2003 in Houston, Texas.
•
Kirsch, Daniel L. Postmarketing survey of Alpha-Stim CES patients. Summarized here and
presented in detail in the book The Science Behind Cranial Electrotherapy Stimulation, 2nd Ed.,
Medical Scope Publishing Corporation, Edmonton, Alberta, Canada, 2002.
•
Schroeder, M.J., and Barr, R.E. Quantitative analysis of electroencephalogram during cranial
electrotherapy stimulation. Clinical Neurophysiology. 112:2075-2083, 2001. Doctoral dissertation,
The Graduate School of the University of Texas at Austin, 191 pages, 1999
Anxiety: CES Research References
•
Annibali, Joseph. Case of the Week: Jeff -- Bipolar Disorder and More. Published online at
http:// www.amenclinica.com/blog/tag/alpha-stim-100, April 22, 2010.
•
Bystritsky, Alexander, Moody, Teena, Hembacher, Emily, Hoffman, Jordan, Moller, Hayley,
Feusner, Jamie. Effects of cranial electrotherapy stimulation on brain activity in the resting
state. Poster presented at the American Society of Neuropsychopharmacology (ACNP),
Hollywood, Florida, December 8, 2009.
•
Kim, Hyun Jung, Kim, Woon Young, Lee, Yoon Sook, Chang, Moon Seok, Kim, Jae Hwan,
and Park, Young Cheol. The effect of cranial electrotherapy stimulation on preoperative
anxiety and hemodynamic responses. Korean Journal of Anesthesiology, 55(6): 657- 661,
2008.
•
Bystritsky, Alexander, Kerwin, Lauren and Feusner, Jamie. A pilot study of cranial
electrotherapy stimulation for generalized anxiety disorder, Journal of Clinical Psychiatry,
69:412-417, 2008.
•
Kirsch, Daniel L. and Gilula, Marshall. Cranial electrotherapy stimulation in the treatment of
anxiety disorders: statistical considerations – Part 2. Practical Pain Management, 7(3):22-39,
2007.
•
Kirsch, Daniel L. and Gilula, Marshall. A review and meta-analysis of cranial electrotherapy
stimulation in the treatment of anxiety disorders – Part 1. Practical Pain Management,
7(2):40-47, 2007.
Thoughts/Questions
Contract Information:
Cynthia Gragnani, Ph.D.
Walter Reed Army Medical Center
Phone: 202-782-8820
Email: [email protected]