getting better with electricity · global effect (side effects) 19th century approach electrical...

Wouter A. Serdijn 18-5-2016

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18-5-2016

GETTING BETTER WITH ELECTRICITYElectronic Medicine to the RescueWouter A. Serdijn, PhD F-IEEE

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BIANCA SAEZ, SUFFERING FROM TOURETTE’S SYNDROME

https://www.youtube.com/watch?v=0OPqGx6fSPU


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1. Neurostimulation

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THE BRAIN: OUR MAINFRAMEAn electro-chemical machine

Chemical component“Cure using medicine”

Global effect (side effects)19th century approach

Electrical component“Cure using electricity”

Local effectInstantaneous and reversible 21st century approach


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NEUROSTIMULATION

Electrodes implanted in the brain- Suppress undesired activity- Generate therapeutic activity

Pulse generator in the chest- Generates electric pulses

Picture courtesy of Medtronic, Inc.

Wires (leads)- Connect the electrodes to the pulse generator

Current treatment

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NEUROSTIMULATION EXAMPLE

Deep Brain Stimulation of the Subthalamic Nucleus for treatment of Parkinson’s disease

Stimulator off Stimulator on

https://www.youtube.com/watch?v=VLmq-MRgwQM


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NEUROSTIMULATION EXAMPLE

Deep Brain Stimulation of the Subthalamic Nucleus for treatment of Parkinson’s disease

Stimulator off Stimulator on

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NEUROSTIMULATORSThe future

Miniaturization

Use new circuit techniques and alternative forms of stimulation to:

1. Make implants fully implantable in the head• Drastically decrease their power consumption• Make them flexible

2. Make impants smart• Close the loop by including feedback

2 mm


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[Source: De Volkskrant, dd. 12/10/13]

Would it be possible to treat rheumatoid arthritis without drugs? Oddly, it appears to be possible. With

a subcutaneously implanted chip, as was discovered by …

The medicine of the future you’ll need to

take only once.

This is not a chip!This is a flexible PCB

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THIS IS A CHIP: A 16-CHANNEL UHF NEUROSTIMULATOR IC WITH RECORD POWER EFFICIENCY

This tiny neurostimulator IC can drive 16 stimulation channels simultaneously with an unprecedented energy efficiency. Designed by Marijn van Dongen. Support by and in collaboration with the SINs consortium

1,6 mm

2,1 mm


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2. Closing the loop

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TINNITUS (INTRO)

https://www.youtube.com/watch?v=fIAjJogJ0cs


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TINNITUS

• = the perception of sound without a corresponding external sound

• Due to a restructuring of the auditory cortex

• More than half a billion people suffer from tinnitus worldwide

• In 2% - 3% of the population, tinnitus can lead to insomnia, anxiety and depression.

• No proven treatments for tinnitus

• However, some patients benefit from electrical brain stimulation.

http://instagram.com/marleen.serdijn/

[Reference: Dirk de Ridder et al: Magnetic and electrical stimulation of the auditory cortex for intractable tinnitus, J Neurosurg 100:560–564, 2004]

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TINNITUS DETECTION AND TREATMENT

Current stimulation

• requires a patients subjective opinion to select an individualized stimulation therapy.

Future stimulation

• Based on an automatic, objectivetinnitus detector

• to automatically adapt and choose stimulation therapy, in a closed-loop manner.

theta

alpha gamma

[Reference: Dirk de Ridder et al: Theta-gamma dysrhythmia and auditory phantom perception, J Neurosurg. 2011 Apr;114(4):912-21]


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NEURAL RECORDING AMPLIFIER IC

1,2 mm

1,75 mm

An additive companding neural recording amplifier IC that can read tiny neural signals on top of the stimulus and artefact, by Cees-Jeroen Bes, in collaboration with LUMC-ENT. Support by STW, TMSi, AB-Sys, 2BMedical and HealthTech

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3. Where it all may lead to


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THE PLAN

Picture courtesy of University of Pennsylvania

• To design a flexible brain implant for the effective treatment of tinnitus, epilepsy and addiction

• That serves as a platform for various types of implantables

• Use silicon and graphene as base materials for the

• Electrodes

• Electronic circuits

• To measure the brain signals

• To electrically stimulate tissue and organs

• To power and control the implant

• Battery foil

• Conductive polymer for the antenna

• For RF energy harvesting

• And wireless communication

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MEDICAL IMPACT – PERIPHERAL NERVOUS SYSTEM

[Reference: Kevin J. Tracey: Electronic Medicine Fights Disease -- Stimulation of the nervous system could replace drugs for inflammatory and autoimmune conditions, Scientific American, March 2015]


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MEDICAL IMPACT – SENSES AND CENTRAL NERVOUS SYSTEM

• Restore hearing (cochlear implant)

• Restore sense of balance (vestibular implant)

• Restore sight (ocular implant)

• Restore smell and taste (olfactory implant)

• Better understanding of the central nervous system

• Better treatment of pain (spinal cord implant)

• Better understanding of the brain

• Better brain-machine interfaces

Spinal cord implant, by Vasiliki Giagka et al., Biomedical Microdevices, Vol.17 (6), pp. 106 - 118, Dec. 2015. DOI 10.1007/s10544-015-0011-5

A vestibular implant

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MEDICAL IMPACT – THE BRAIN Better treatment of brain disorders• Better treat tinnitus and auditory hallucinations, • Better treat addictions (a.o. alcoholism), • Better treat essential tremor, Parkinson, dystonia• Better treat urge incontinence, • Better treat migraine, cluster headaches and other forms of

headache• Better treat psychoneuroimmunological disorders• Better treat chronic, phantom and neuropathic pain, • Better treat depression, mania• Better treat OCD spectrum disorders • Better treat PTSD and anxiety• Better treat schizophrenia• Better treat epilepsy• Treat autism, • Treat dementia, including Alzheimer’s disease• Treat Tourette’s syndrome, minimally conscious state

(MCS) after traumatic brain injury, obesity, anorexia

[Reference: C.O. Oluigbo, A.R. Recai, Addressing Neurological Disorders With Neuromodulation, IEEE Transactions on Biomedical Engineering, Vol. 58, No. 7, July 2011]


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4. Policies, regulations, ethics

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2 VALLEYS OF DEATH


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FDA “IS KILLING INNOVATION IN MEDICAL TECHNOLOGY”

• U.S. Food and Drug Administration

• Traditionally focussed on pharma

• Lengthy reviewing processes

• It has become too difficult, too costly and takes too long to get products approved

• “complaints from the investor community about the unpredictability, inefficiency and opacity of the approval process”

• “FDA has been in a defensive crouch when it comes to clearing new products”

• “so much of it is stifled by the FDA clinical trial process, meaning all sorts of useful products never actually make it to market”

• American companies look at Europe for product innovation (and funding opportunities)

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SITUATION IN THE EU

• Existing EU rules – dating back to the 1990s – have not kept pace with the enormous technological and scientific progress in the past 20 years.

• EU countries interpret and implement the current rules in different ways.

• It is not always possible to trace medical devices back to their supplier. New rules on traceability are needed.

• Patients, healthcare professionals and other interested parties do not have access to essential information on how medical devices have been assessed, and what clinical evidence there is to show they are safe and effective.

• Laws and ethics can’t keep pace with technology

Revisions of Medical Device Directives(2012-2016 (?))


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Martec’s Law

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ETHICS

• Just like pharmaceuticals, electroceuticals may have side effects:

• Direct side effects, which, fortunately, contrary to pharmaceuticals, are instantaneous and reversible

• Indirect side effects, as the brain may get used to the treatment and habituate, which renders the treatment to be less effective.

• Indirect side effects, as the brain may become addicted to the treatment

• Electroceuticals might block sleepiness, pain, emotions, feelings

• Electroceuticals might give you night vision, ultrasound hearing, pump up your adrenaline

• Electroceuticals might give you true direct communication


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https://www.youtube.com/watch?v=VCYrW-G9Y6I


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HEALTH-RELATED QUALITY OF LIFE (HRQOL)

Adverse Drug Reaction


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18-5-2016

GETTING BETTER WITH ELECTRICITYElectronic Medicine to the RescueWouter A. Serdijn, F-IEEE

getting better with electricity · global effect (side effects) 19th century approach electrical...

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