The Management of Anxiety, Depression, PTSD, Insomnia and Pain

Cranial Electrotherapy Stimulation (CES)

© Copyright 2016 Electromedical Products International, Inc. , Mineral Wells, Texas, USA ALL RIGHTS RESERVED

Josh Briley, Ph.D., FAIS

Financial Disclosure

Josh Briley, Ph.D., FAIS

Relevant Financial Relationship:

• Is an employee of Electromedical Products

International, Inc. (EPII) and receives a salary.

• EPII manufactures and sales Alpha-Stim CES devices

What is Cranial

Electrotherapy Stimulation

(CES)?• It is a noninvasive, safe, and effective form

of neurostimulation that can be performed by

the clinician, or the patient at home, and is

cost effective.

• It sends very tiny electrical signals into the

brain by electrodes.

• In 38 years, no dangerous side effects have

ever been reported.

Feelings Experienced During CES

Treatment Stages

Dosage equals time inversely proportional to current level.

Therefore, less current requires longer treatment time per session.

SLEEPY

AWAKE

TIME

ALERT

20 minutes to

1 or more hours

HEAVY, GROGGY, EUPHORIC (never stop here)

No “brainfog,” vision is

clear and patients feel

energetic as if they

slept soundly all night

LIGHT FEELING

Kirsch, Daniel L. and Nichols, Francine. Cranial electrotherapy stimulation for treatment of anxiety, depression and insomnia.

Psychiatric Clinics of North America. 2013; 36(1):169-176.

(A) Electrical synapses are much faster but get weaker over distances. Gap junctions between pre- and postsynaptic membranes permit current to flow passively through intercellular channels. This current flow initiates or inhibits the generation of postsynaptic action potentials.

(B) Chemical synapses are slower but exhibit gain (strengthening signal). There is no intercellular continuity, and thus no direct flow of current from pre- to postsynaptic cell. Current can only flow across the postsynaptic membrane in response to the secretion of neurotransmitters which open or close postsynaptic ion channels after binding to receptor molecules.

Purves, Dale and Augustine, George J. et al. Neuroscience, 2nd Ed. Sinauer, Sunderland, MA , 2001.

Electrical and

chemical

synapses

differ

fundamentally

in their

transmission

mechanisms

Models of Receptor Activation

21st

Century

The New Theory:

Physical/

Atomic

Electromagnetic

Communication

19th & 20th

Century

The Old Theory:

Structural

Matching;

Chemical/

Molecular

Physical

Communication

The 3D nature of the ligand matches the receptor.

Physical proximity induces receptor conformational

changes which triggers the cascade of events

prompting cell function.

Proximity favors co-resonance of specific

bioelectrical signals with frequencies that perfectly

match the resonance of the receptor to amplify

molecular conformational changes at all steps of

the cascade prompting cell function, even from long

distances (like tuning in a radio).

Benveniste, J. A fundamental basis for the effects of EMFs in biology and medicine: The interface between matter and function. Chapter 13 in Bioelectromagnetic Medicine. Rosch, P and Markov, M, eds. Marcel Dekker, New York, 2004.

Putative Mechanism of CES

Giordano, James. Illustrating how CES works. Insert in

Kirsch, Daniel L. Cranial electrotherapy stimulation for the

treatment of anxiety, depression, insomnia and other

conditions. Natural Medicine. 2006; 23:118-120.

CES engages the serotonergic (5-HT)

raphe nuclei of the brainstem. 5-HT

inhibits brainstem cholinergic (ACh) and

noradrenergic (NE) systems that project

supratentorially. This suppresses thalamo-

cortical activity, arousal, agitation, alters

sensory processing and induces EEG

alpha rhythm. 5-HT can also act directly to

modulate pain sensation in the dorsal

horn of the spinal cord, alter pain

perception, cognition and emotionality

within the limbic forebrain.

Legend:

Blue arrows: inhibitory interactions

Purple arrows: excitatory interactions

X: suppressed pathways/interactions

ACh

LDT

PPN

NE

LC

5-HT

Acetylcholine

Laterodorsal Tegmental Nucleus

of the brainstem

Pediculo-Ponitne nucleus of the

brainstem

Norepinephrine

Locus Dceruleus

Serotonin

QEEG Changes in 30 Subjects Treated with 20 Minutes of CES

There is an increase in alpha activity with a simultaneous decrease in delta.

Blue = decrease Red = increase

Kennerly, Richard. QEEG analysis of cranial electrotherapy: a pilot study.

Journal of Neurotherapy, (8)2, 2004.

Presented at the International Society for Neuronal Regulation conference, September 18-21, 2003, Houston, Texas

Decrease DeltaMore alert

Increase AlphaMore relaxed

Low Resolution Tomography

Paired t-test for 8 Hz LORETA: Significant alpha wave increases after 20 minutes of 0.5 Hz CES

Kennerly, Richard C. Changes in quantitative EEG and low resolution tomography following cranial electrotherapy stimulation.

Ph.D. Dissertation, the University of North Texas. 529 pp., 81 tables, 233 figures, 171 references, 2006.

State (Situational) Anxiety

State anxiety can be effectively treated in a single CES

treatment session.

Results will vary based on initial

anxiety level, length of treatment,

comorbidities and overall patient

health.

This is demonstrated in medical and

dental studies and in mechanistic

studies of EEG and fMRI changes

from a single CES treatment.

Change in Multiple Stress Measures

from a Single CES Treatment

Heffernan, Michael. The effect of a single cranial electrotherapy stimulation on multiple stress measures.

The Townsend Letter for Doctors. 147:60-64, 1995.

Presented at the Eighth International Montreux Congress on Stress,Montreux, Switzerland, February, 1996.

CE

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roup

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ols

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roup

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ols

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roup

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ols

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scle

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nsio

n

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scle

Te

nsio

n

Pu

lse

Pu

lse

Te

mp

era

ture

Te

mp

era

ture

-3

-2

-1

0

1

2

3

4

5

Nu

mb

er

of

Scale

Po

ints

of

Imp

rovem

en

t

Stress Measure

P<0.05

Trait (Chronic) Anxiety

May require up to 6 weeks of CES

treatments, 2-3 times per week, to see

significant reduction in trait anxiety and

GAD levels.

Treatment outcome may also depend

on comorbidities such as depression

and insomnia.

Patients diagnosed with Generalized Anxiety Disorder (GAD) have higher

scores on trait anxiety and depression tests, more negative beliefs about

worry, a greater range of worry topics, and more frequent and severe

negative thought intrusions.

Anxiety Improvement in Advanced Cancer Patients

Yennurajalingam S, Kang D-H, Hwu W-J, Padhye NS, Masino C, Dibaj SS, Liu DD, Williams JL, Lu Z, Bruera E. Cranial electrotherapy stimulation for the management of depression, anxiety, sleep disturbance, and pain in patients with advanced cancer: a preliminary study. Journal of Pain and Symptom

Management. 2018; 55(2): 198-206.

8.81

6.89

6.426.24 6.16

5

5.5

6

6.5

7

7.5

8

8.5

9

9.5

Baseline Week 1 Week 2 Week 3 Week 4

Mean anxiety scores in advanced cancer patients

Hospital Anxiety and Depression ScaleN= 33p<0.001

Anxiety

Kim HJ, Kim WY, Lee YS, Chang M, et al. The effect of cranial electrotherapy stimulation on preoperative anxiety and hemodynamic

responses. Korean Journal of Anesthesiology. 2008; 55: 657- 661.

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, HI, July 2013.

Anxiety

Cork, Randall C., Wood, Patrick, Ming, Norbert, Shepherd, Clifton, Eddy, James and Price, Larry. The effect of cranial electrotherapy stimulation

(CES) on pain associated with fibromyalgia. The Internet Journal of Anesthesiology. 2004; 8(2).

Winick, Reid L. Cranial electrotherapy stimulation (CES): A safe and effective low cost means of anxiety control in dental practice.

General Dentistry. 1999; 47(1): 50-55.

Anxiety

Voris, Marshall D. An investigation of the effectiveness of cranial electrotherapy stimulation in the treatment of anxiety disorders among outpatient psychiatric patients, impulse control parolees

and pedophiles. Delos Mind/Body Institute Newsletter. 1995.

Dallas and Corpus Cristi, Texas.

Bystritsky A, Kerwin L and Feusner J. A pilot study of cranial

electrotherapy stimulation for generalized anxiety disorder.

Journal of Clinical Psychiatry. 2008; 69:412-417.

PTSD in a 54 Year Old Male Veteran

Overall Decrease in Severity

of 39% in One Month

PTSD Symptom

Scale – Interview

(PSS-I)PRE POST

PSS-I

(Range: 0-51) 34 13

Re-experiencing

(0-15) 7 2

Avoidance

(0-21) 15 7

Increased Arousal

(0-15) 12 4

Bracciano, Alfred G., Chang, Wen-Pin, Kokesh, Stephanie, Martinez, Abe, Meier , Melissa and Moore, Kathleen.

Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder:

A Pilot Study of Two Military Veterans. Journal of Neurotherapy. 2012; 16(1): 60-69,.

Childs, Allen and Price, Larry. Cranial electrotherapy stimulation reduces aggression in violent neuropsychiatric patients.

Primary Psychiatry. 2007; 14(3): 50-56. Presented at American Psychiatric Association annual meeting, 2007.

0

200

400

600

800

1000

1200

1400

Aggressive

episodes

Seclusions Restraints PRN Meds

Incid

en

ts

Pre CES

Post CES

3 Month Trial with 48 Severe Aggressive

Neuropsychiatric Patients

The decrease of 271 PRN emergency medicine doses in 3 months

saved more than $12,000 for these medication expenses alone.

44% decrease

p<.001

40%

p<.05

40%

p<.001

42%

p<.01

Insomnia

Insomnia patients usually see results after one treatment.

Or it may take up to 4 weeks of treatment, especially if insomnia is associated with depression.

Typically better results are seen with sleep onset insomnia but CES may also help with sleep continuity for people who do not experience alertness. Treat at least 3 hours before bed.

Insomnia

Lande RG and 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.

Taylor AG, Anderson JG, Riedel SL, Lewis JE, et al. A randomized,

controlled, double-blind pilot study of the effects of cranial electrical

stimulation on activity in brain pain processing regions in individuals

with fibromyalgia. Explore. 2013; 9(1): 32-40.

Insomnia

Lichtbroun, Alan S., Raicer, Mei-Ming C. and Smith, Ray B.

The treatment of fibromyalgia with cranial electrotherapy stimulation.

Journal of Clinical Rheumatology. 2001; 7(2): 72-78.

Depression

Expect a minimum of 3 - 6 weeks of daily CES treatment before significant results are seen

A patient who suffers from anxiety with a depression component will take up to one month to improve as well

After 6 weeks, treat 1 - 2 times per week

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, HI, July 2013.

82.2% of the active group reported at least 50% improvement.The active group reported 12 times more improvement than the sham group.

14.51

9.64

8.16.47

13.22

10.229.86 9.96

6

7

8

9

10

11

12

13

14

15

Baseline Week 1 Week 3 Week 5

Ad

just

ed

Me

ans

fro

m B

ase

line

Active Treatment (N=58) Sham Treatment (N=49)

Mean Depression Scores

N = 107

P=0.001

d=0.75

HAM-D

Depression

Chen Y, Yu L, Zhang J, Li L, et al. Results of cranial electrotherapy stimulation to children with mixed anxiety and depressive disorder.

Shanghai Archives of Psychiatry. 2007; 19(4): 203-205.

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, HI, July 2013.

Depression

Amr, Mostafa, El-Wasify, Mahmoud, Elmaadawi, Ahmed, Roberts,

Jeannie, and El-Mallakn, Rif. cranial electrotherapy stimulation for

the treatment of chronically symptomatic bipolar patients.

Journal of ECT. 2013; 29(2): 31-32.

Bystritsky A, Kerwin L and Feusner J. A pilot study of cranial

electrotherapy stimulation for generalized anxiety disorder.

Journal of Clinical Psychiatry. 2008; 69:412-417.

Pain Management

• Acute

• Chronic

• Post-traumatic

Pain relief is cumulative with continued use.

Results are usually seen from the first treatment.

There is no risk of accommodation or

addiction.

Perspective:

The average pain

reduction from

long-term use of

analgesic drugs

is only 32%!

Most of the CES

and MET research

shows effects above

(in addition to)

drug effects.

Tan Gabriel and Jensen Mark P.

Integrating complementary and alternative medicine

(CAM) into multidisciplinary chronic pain treatment.

In Multidisciplinary Chronic Pain Management:

a Guidebook for Program Development

and Excellence of Treatment.

Schatman and Campbell (editors),

Taylor & Francis, 2007; 75-99,

What is the first thing you think

of treating when you have pain?

Pain

Taylor AG, Anderson JG, Riedel SL, Lewis JE, et al.

A randomized, controlled, double-blind pilot study of the effects of cranial electrical stimulation on activity in brain pain processing regions in individuals with fibromyalgia. Explore. 2013; 9(1): 32-40.

Pain in Fibromyalgia Patients

Pain

Lichtbroun, Alan S., Raicer, Mei-Ming C. and Smith, Ray B.

The treatment of fibromyalgia with cranial electrotherapy

stimulation. Journal of Clinical Rheumatology. 2001; 7(2): 72-78.

Cork, Randall C., Wood, Patrick, Ming, Norbert, Shepherd, Clifton, Eddy, James and Price, Larry. The effect of cranial electrotherapy stimulation

(CES) on pain associated with fibromyalgia.

The Internet Journal of Anesthesiology. 2004; 8(2).

Pain

Tan G, Rintala D, Herrington R, Yang J, Wade W, Vasilev C. and Shanti BF.

Treating spinal cord injury pain with cranial electrotherapy stimulation.

Journal of Spinal Cord Medicine. 2003; 26(3).

Active Sham

Pain Reduction in Advanced Cancer Patients

3.74

2.912.8 2.77

2.65

2

2.5

3

3.5

4

Baseline Week 1 Week 2 Week 3 Week 4

Mean pain scores in advanced cancer patients

Brief Pain InventoryN= 33p=0.013

Yennurajalingam S, Kang D-H, Hwu W-J, Padhye NS, Masino C, Dibaj SS, Liu DD, Williams JL, Lu Z, Bruera E. Cranial electrotherapy stimulation for the management of depression, anxiety, sleep disturbance, and pain in patients with advanced cancer: a preliminary study. Journal of Pain and Symptom

Management. 2018; 55(2): 198-206.

Pain

Rintala, Diana H., Tan, Gabriel, Willson, Pamela , Bryant, Mon S. and Lai, Eugene C. H. Feasibility of using cranial electrotherapy

stimulation for pain in persons with Parkinson’s disease. Parkinson’s Disease. 2010; 8 pages.

Authors’ Conclusion:

Use of CES at home by persons

With PD is feasible and helpful

in decreasing pain

Holubec, Jerry T. Cumulative Response from Cranial Electrotherapy Stimulation (CES) for Chronic Pain.

Practical Pain Management. 2009; 9(9): 80-83.

42%, N=525

50%, N=261

54%, N=160

64%, N=57

71%, N=26

40%

45%

50%

55%

60%

65%

70%

75%

1 2 3 4 5

CES Treatment Sessions

Pe

rce

nt

Re

du

ctio

n in

Pai

n L

eve

lsCumulative Improvement in Pain After 1-5 CES Treatments

Example of the CES Response Over Time

in a Patient with Severe MigraineCourtesy of COL Michael Singer, Walter Reed National Military Medical Center

Stay with it!

0

2

4

6

8

10

0 60 120 180

Pain Level

Minutes

fMRI RCT on CES Activity in Brain Pain

Processing Regions in Fibromyalgia Patients

Subjects using an active CES device showed deactivation in the pain processing regions of the brain compared to those using a sham device.

Taylor, Ann G., Anderson, Joel G., Riedel, Shannon L., Lewis, Janet E. and Bourguignon, Cheryl.

A randomized, controlled, double-blind pilot study of the effects of cranial electrotherapy stimulation on

activity in brain processing regions in individuals with fibromyalgia. Explore. 2013; 9(1): 32-49,

CES May Replace Medications

• CES may replace some medications

• Current medications may be potentiated by 1/3 to 1/2

• To reduce medication dosages

– Slowly taper, monitor symptoms, trial and error

Medication

CES

Time

Summary

• CES is safe

• CES is easy to use

• CES is proven effective

• CES works quickly and lasts

• CES is FDA, CFDA, CE and ISO certified

• US Military is using and researching CES

• CES is available to help you NOW!

Why Not Use CES?