Transcript TheraMind TMS

Transcranial Magnetic Stimulation (“TMS”)
TheraMind Services, Inc.
Energizing brains…Healing Minds
TM
Major Depressive Disorder (“MDD”):
Circuits and Neurotransmitters
concentration
pleasure/interests
psychomotor fatigue (physical)
pleasure/interests
sleep
appetite
psychomotor
fatigue (mental)
monoamine
neurotransmitter
projections
mood
• Monoamine dysfunction
is linked to MDD
• Malfunctioning circuits
lead to specific
symptoms
guilt
suicidality
worthlessness
mood
Regions implicated in
MDD are connected to
the brainstem via
monoaminergic circuits
When there is an
appropriate amount
of monoamine
neurotransmitter
activity, neuronal
activity throughout
the brain functions
normally.
Monoamine Neurotransmitters: Serotonin (5-HT); Dopamine (DA); and, Norepinephrine (NE).
agitation
blurred vision
insomnia
dry mouth
nausea
insomnia
GI distress
improved
mood
fatigue
sexual
dysfunction
reduced feelings of
guilt, suicidality,
and worthlessness
weight
gain
Blood pressure
changes
Chemical Antidepressants
weight gain
Depolarization leads to action
potentials in local neurons and
thereby releases
neurotransmitters
Neuron
Neurons are
electrochemical cells that
respond to either electrical
or chemical stimulation
Rapidly pulsed
magnetic fields from
TMS :
• induce a local
electric current in
the cortex which
depolarizes neurons
• elicit action
potentials
• cause the release of
chemical
neurotransmitters
TMS Releases Neurotransmitters
in the Brain
These effects are
associated with
improvements in
depressive
symptoms
Depolarization of neurons in the Dorsolateral
Prefrontal Cortex causes local neurotransmitter
release
Depolarization of pyramidal
neurons in the DLPFC
causes neurotransmitter
release in deeper brain
neurons
Dorsolateral
prefrontal
cortex
Cingulate
cortex
Activation of deeper brain neurons then exerts secondary
effects on remaining portions of targeted mood circuits
Brain SPECT
Kito (2008) J Neuropsychiatry Clin Neurosci
TheraMind Patient 101
Beck score measured
during acute phase of
treatment
TheraMind Patient 102
60
Beck score measured
during acute phase of
treatment
40
40
30
20
20
10
0
Week 1
Week 2
Week 3
Week 4
Week 5
0
Week 1
Week 2
Week 3
Classification
Total Score
Level of
Depression
Low
0-10
Normal
11-16
Mild Mood
Disturbance
17-20
Borderline clinical
depression
21-30
Moderate
Depression
31-40
Over 40
Severe Depression
Extreme
Depression
Moderate
Significant
Week 4
Week 5
Optimization of TMS (‘OPTTMS’) Study
Mark S. George, MD; Sarah H. Lisanby, MD; David Avery, MD; William M. McDonald, MD; Valerie Durkalski, PhD;
Martina Pavlicova, Phd; Berry Anderson, PhD, RN; Ziad Nahas, MD; Peter Bulow, MD; Paul Zarkowski, MD;
Paul E. Holtzheimer III, MD; Theresa Schwartz, MS; Harold A. Sackeim, PHD
Major Findings:
• NIMH-funded, independent of industry
• 30% of patients achieved remission
• N=190 patients, 4 premier academic sites
in open-label extension phase
• Primary outcome measure:
• Excellent safety, nearly 90% of
% Remission - Active 15% vs. Sham 4% (P
patients adherent to acute phase
= 0.015); Odds Ratio of achieving remission: 4.2
treatment course
(95%CI, 1.3-13.2)
Conclusion: “Daily left prefrontal rTMS as monotherapy
produced statistically significant and clinically meaningful
antidepressant therapeutic effects greater than sham.”
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Randomized Controlled Trials
John P. O’Reardon, H. Brent Sovason, Philip G. Janicak, Shirlene Sampson, Keith E. Isenberg, Ziad Nahas, William M. McDonald,
David Avery, Paul B. Fitzgerald, Colleen Loo, Mark A. Demitrack, Mark S. George, and Harold A. Sackeim
BIOL PSYCHIATRY 2007;62:1208-1216 ©2007 Society of Biological Psychiatry
Major Findings:
• N=301 patients (ATHF 1 thru 4), 23
sites
• 22.1% reduction in MADRS total
score with active NeuroStar TMS vs.
9.1% on sham at 4 weeks (in ATHF
= 1 population)
• Clinically meaningful effect size =
0.52 (in ATHF = 1 population)
• In open label extension study, 1 in 2
patients responded, 1 in 3 patients
achieved remission at 6 weeks
• Safety confirmed in 6 month followup
Conclusion: “Transcranial Magnetic Stimulation was
effective in treating major depression with minimal side effects
reported. It offers clinicians a novel alternative for the
treatment of this disorder.”
Demitrack & Thase (2009) Psychopharm Bulletin
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In a controlled clinical study, 1
in 2 patients suffering from
clinical depression improved
significantly, and 1 in 3
patients were completely free
of depression symptoms after
six weeks of treatment.
Other TMS providers are
reporting 80% of their
patients treated have
significantly improved in their
mood, energy and motivation.
1. Demitrack, MA, Thase ME. “Clinical significance of transcranial magnetic stimulation (TMS) in the treatment of
pharmacoresistant depression: synthesis of recent data.” Psychopharm Bull, 2009, 42(2): 5-38. 2. Premier Psych
TMS, Walter Duffy, MD. Lincoln, Nebraska.
Summary
TheraMind Services TMS Therapy…

Specifically targets the brain circuits involved in
mood regulation

Directly depolarizes cortical neurons and
modulates neurotransmitter release in the brain

Effects involve both the cortical and deep neural
circuits in the brain

Accomplishes these effects without unwanted
systemic adverse effects
TMS Benefits Patients in Real World
Settings

Prospective, naturalistic study confirms prior
trial results for both clinician- and patientreported outcomes in real-world practice
settings

Some TMS providers are reporting 80% of
their patients treated have significant
improvement in their mood, energy and
motivation. Premier Psych TMS, Walter Duffy, M.D., Lincoln, Nebraska

Patient-reported outcomes showed
improvements both in quality of life and
functional status

High level of treatment adherence, >80% of
patients completed acute treatment
TheraMind TMS Systems:
Safety Overview

No systemic side effects

No adverse effect on cognition

Most common adverse event associated with
treatment was scalp pain or discomfort
- <5% of patients discontinued due to adverse events

Rare risk of seizure with TMS in post-market use
(0.003% per treatment, <0.1% per patient)
- (~100,000 treatments in post-marketing experience to date)

Long term safety demonstrated in 6 months follow-up
Janicak, et al J Clin Psychiatry, 2008; Janicak, et al. Brain Stimulation, 2010
Energizing brains...Healing minds.™