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TMS   Transcranial Magnetic Stimulation TMS   Transcranial Magnetic Stimulation

TMS Transcranial Magnetic Stimulation - PowerPoint Presentation

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TMS Transcranial Magnetic Stimulation - PPT Presentation

TMS is a noninvasive procedure using an electromagnetic coil The coils generate repetitive changing magnetic fields which create an electric field  The activity in the neurons modulates brain activity both locally and in connected brain circuits ID: 917661

cleared tms fda patients tms cleared patients fda depression prior devices resistant pain anxiety treatment coil amp remission press

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Slide1

TMS Transcranial Magnetic Stimulation

Slide2

TMS is a noninvasive procedure using an electromagnetic coilThe coils generate repetitive changing magnetic fields which create an electric field.  The activity in the neurons modulates brain activity both locally and in connected brain circuits.Most indications require a series of treatments on consecutive days (e.g. for depression this number can vary from 36-51+)Coils for depression are all designed slightly different, but clinically most FDA Cleared coils are Figure of 8 shaped.  One coil is a unique geometry called Hesed

-Coil (H1-Coil).

What is TMS?

Slide3

TMS Devices Currently FDA-Cleared ForMajor Depressive Disorder

Neuronetics

NextStim

MagVenture

CloudTMS

M

ag & More

Magstim

Brainsway

Slide4

TMS is FDA cleared for:

Treatment resistant MDD in adult patients

1

(7 devices cleared)

- No satisfactory improvement from (or sensitivity/allergy to) 1, or more, antidepressant medications at or above the minimal effective dose & duration in the current episode of depression. Despite this indication, i

nsurers can require 2-4+ med trials, +/- trial of evidence-based psychotherapy

Treatment resistant Obsessive Compulsive Disorder (OCD), in adult patients

2,3

(2 devices cleared)

Migraines with

aura

4

(single pulse TMS, 1 device cleared)

Smoking cessation

5

(1 device cleared)

Indications with Promising Data:

Level A/B evidence7Neuropathic Pain

6Post-Stroke7

PTSD7

Fibromyalgia

7

1

McIntyre R et al. J Clinical Psychiatry, 2017

2

Press Release from FDA August 17, 2018

3

Press Release from FDA August 11, 2020

4

Lan et al. J Headache Pain

, 2017

5

Press Release from FDA August 24, 2020

6

Hamid P, et al. 2019​

7

Lefaucheur, JP et al. 2020

Slide5

TMS vs. Antidepressant MedicationNo systemic side effects - insomnia, fatigue, blurred vision, GI distress, sexual dysfunction, dry mouth, tremor, autonomic instability, etc. (as with medications)No known cognitive side effects

Noninvasive - No need for sedation, anesthesia, hospitalization, or recovery time (as with ECT, DBS, VNS)

Effective in treatment resistant depression (TRD) where medications can have diminishing returns

1,2,3,4

1

A

very et al. (2008)

J Clin Psych

2

Carpenter et al. (2012) Depress Anxiety

3

Connolly et al. (2012) J Clin Psych4 Fava et al. (2006)

Am J Psychiatry5 Trivedi et al. (2006)

Am J Psychiatry

Remission Rate As A Function of Medication Resistant Level (STAR*D Results)

1

One prior failureNo or Limited Prior Anti-depressant TreatmentTwo prior failuresThree prior failures

Slide6

Remission from Depression is possible with TMS Therapy:

Percent of Patients

(N=307)

Responders (CGI-S ≤3, PHQ-9 <10)

Remitters (CGI-S ≤2, PHQ-9 <5)

LOCF Analysis of intent-to-treat population

Clinician Rating

(CGI-Severity of Illness)

Patient Rating

(PHQ-9 Scale)

Carpenter et al. (2012)

Depression and Anxiety

1 in 2 Patients Respond

1 in 3 Patients Achieve Remission

Slide7

TMS Therapy is Well-Tolerated and Safe for Most Patients

Side Effects

1

Application site discomfort/pain

Headache

Referred (eye, tooth, jaw) discomfort/pain

Insomnia

Anxiety

1

510(k) applications for

Neuronetics

& Brainsway devices for MDD

Contraindications:

Non-removable metal objects in or around head

~50%

~5%

Not Contraindicated:

Tattoos

Dental metal (braces, bridges, implants, or fillings)

Slide8

Conclusion

TMS is...

a f

ocal, non-invasive form of brain stimulation

in clinical use for

nearly 20 years

safe for almost all patients

very well-tolerated

FDA cleared for patients with MDD and OCD who do not benefit sufficiently from, or tolerate, pharmacotherapy

FDA cleared for smoking cessation and migraine with aura