Ethical Implications of Thync Device

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The Thync Device Aleksandra Golebiowska, Daniel Griepp, Jurinus Lesporis, and Brian Wang

Transcript of Ethical Implications of Thync Device

Page 1: Ethical Implications of Thync Device

The Thync Device

Aleksandra Golebiowska, Daniel Griepp, Jurinus Lesporis, and Brian

Wang

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IntroductionMeet the Thync Device.

What is the biomedical problem?

How is the physiology defined as an engineering problem?

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Background: Emotions● Subjective mental state that is usually accompanied by distinctive

behaviors as well as involuntary physiological changes

● Experiencing negative emotions for extended period of time = stress

Rosenzweig, M. R., Breedlove, S. M., & Watson, N. V. (2005). Biological psychology: An introduction to behavioral and cognitive neuroscience. Sunderland, Mass: Sinauer Associates.

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Our Biomedical Problem: Stress● Stress is a biological and psychological response experienced when

encountering kind of demand or threat● Two types of Stress

○ Acute Stress [added to DSM-IV, 1994]■ Daily demands and pressures

○ Chronic Stress■ Persists over an extended period of time■ Traumatic event

https://legacy.wlu.ca/images/page_images/2520/2520_stressed.jpg

Baum, A. (1990). "Stress, Intrusive Imagery, and Chronic Distress," Health Psychology, Vol. 6, pp. 653-675.

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Symptoms of Stress:● Cognitive Symptoms

○ Memory problems, inability to concentrate, anxious thoughts, constant worrying

● Emotional Symptoms○ Moodiness, irritability, feeling overwhelmed, sense of loneliness and isolation,

depression● Physical Symptoms

○ Aches and pains, frequent colds, rapid heartbeat● Behavioral Symptoms

○ Nervous habits, sleeping disruptions, use of alcohol, cigarettes or drugs to relax

http://www.helpguide.org/articles/stress/stress-symptoms-causes-and-effects.htm

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Concentration:

● Inability to concentrate● Lack of motivation● Due to long-term effects of stress

http://zestwap.com/wp-content/uploads/2015/02/concentration.jpg

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How does stress affect our body?● Comes into contact with stressor● Signal sent to amygdala

○ Area of brain responsible for emotional processing● Hypothalamus is alerted

○ Communicates with body through ANS● Pituitary and adrenal glands are triggered

○ Release of adrenalin and cortisol

http://www.health.harvard.edu/staying-healthy/understanding-the-stressBaum, A. (1990). "Stress, Intrusive Imagery, and Chronic Distress," Health Psychology, Vol. 6, pp. 653-675.

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How does stress affect our body?

http://www.health.harvard.edu/staying-healthy/understanding-the-stress-and textbook

https://psychlopedia.wikispaces.com/Fight-or-Flight+Response?responseToken=0aa63459639ceb324d670b52f5b107480

● Stress response○ Sympathetic Nervous System

■ “Fight or Flight”○ Parasympathetic Nervous

System■ “Rest and Digest”

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Society Today:● High stress experienced

○ Stress response is triggered frequently● High level of Cortisol

○ Toxic for hippocampus, dampened thyroid function● Low level of Cortisol

○ Brain fog, fatigue and low blood pressure

https://www.adrenalfatigue.org/cortisol-adrenal-functionresponse

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Current TechnologyThe Thync Device is not alone.

Current Engineering Solutions for the Problem

Implementation in Clinical Use

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Engineering Technology:

● THYNC Device● Transcranial Direct

Current Stimulation (tDCS)● Transcranial Magnetic

Stimulation (TMS)● Foc.us (Gamers

“enhancement” version)

http://soterixmedical.com/1x1/Overview

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Cell Excitability:

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How the THYNC Device Works:● Each emotion influences peripheral nerves in your head and

face.● Thync works using the same pathways by delivering low-level

electrical pulses to these nerves.● Thync uses neuro-signaling to activate specific cranial and

peripheral nerves to influence the balance between the parasympathetic and sympathetic systems.

http://www.thync.com/science-and-technology

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How the THYNC Device Works:First Electrode: Right Temple● Stimulates the maxillary and

ophthalmic branches of the trigeminal nerves.

Calm Vibes: Back of Neck● Activates the C2/C3 cervical spinal

afferent nerves.Energy Vibes: Behind the Ear, the Mastoid ● Activates the Greater Occipital Branch

of C2/C3 spinal branch.

Tyler, J. Thync Inc. Hacking The Brain, time: 53:15, www.youtube.com/watch?v=IFDyYtPou_Uhttp://www.thync.com/products

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Using the THYNC Device:

http://www.thync.com/products

Directions:

1. Buy device for $1992. Place the first electrode on the right

temple.3. Place the second electrode on either the

back of the neck or behind ear.4. Snap device onto the first electrode.5. Open your IPhone to sync the device. 6. Start the calming or energy vibes via

IPhone/IPad.

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Impact on SocietyBeyond the individual.

Benefits to Patients

Benefits to Society

Economic Costs and Prevalence

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Benefits To Patients1. Reduced/Removal of Stress

2. Non-reliance on other outlets for stress

3. Cost effective

4. Safer and Less toxic than mood enhancing drugs

5. Least Lifestyle Invasive

6. Convenient/No Prescription Necessary

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Benefits to Society● Boost to Overall Health and Performance in the

population especially the working class.○ Stress has been correlated with reduced productivity

and increased sick days.

○ Repeated stress exposure has been shown at the

cellular

level to increase physical and mental illnesses

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Benefits to Society (contd)● Allows for resources to be distributed to other

societal issues:

○ Given the relatively inexpensive and one time cost of

Thync Devices over traditional approaches for

treating stress conditions and their risks.

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Economic Costs and Prevalence Based off statistics of World Health Organization, just workplace stress is costing the US economy 300 billion dollars.

It is obvious that every person will experience some acute stress or at least some significant factors that cause stress in a healthy and functioning individual.

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EthicsThe debate begins.

Privacy

Safety and Unintended Use

Cognitive Enhancement & Education

Athletics

“Forced” Treatment

Behavioral Manipulation

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FDA Approval and Classification:“Based on intended use and output characteristics, the FDA notified Thync that its device is not subject to medical device regulations requiring pre-market clearance or approval.”

“The Thync System is a low-risk transdermal neurostimulation device intended for lifestyle use at home, work, or in wellness applications to temporarily induce mental relaxation or calmness or to temporarily increase energy, awareness, and alertness.”

http://www.thync.com/science-and-technology

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Privacy:Device interfaces through an IPhone app. This introduces the possibility of being hacked.

● The Thync device stimulation could be potentially altered by an outside party during use.

○ This could induce physical harm. ● The Thync device could be hacked by an outside party after use.

○ Potential to violate the rights of individuals to privacy.○ This could be used as a way in court to discredit individuals.

■ Legal system may need to evolve in order to determine whether or not this device should be used by public officials.

■ Effects on decision making.○ Potential to blackmail politicians by hacking device history.

■ Possibility of becoming addicted to the vibes.

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Unintended Use:Is it ethical to allow the company to sell this device if it can easily be misused? Should we impose regulations on the company?● “The Thync System is not intended to treat or diagnose any disease or medical

condition.”○ What if it is used by people who want to treat their depression?

● “DO NOT use this device on children under the age of 18”○ What if a parent uses the Thync device to calm down a crying child?

■ Issues of minor safety● “DO NOT place this device across your chest. The introduction of an electrical

current to the chest...could be lethal”○ What if a person using the device does not follow instructions?

■ Argument: Labelling is enough vs changes are required■ Other examples: Labelling requirements for toys1

Quotes from http://www.thync.com/products 1. https://www.law.cornell.edu/uscode/text/15/1278

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Safety:To what extent should Thync factor in safety concerns in its device? Do we need to impose regulations?

● Child-proofing: The Thync device is not child proof; only a warning is given○ If a child is hurt, who is responsible?

■ Argument: Warnings are enough v.s. company needs to make changes to device● Analogues: Gun safety locks, child-proof pill caps

● “Hacking”: The Thync device is not tamper proof○ What if a user believes increasing the output will give better results and tampers with the

device? ■ Argument: User is held responsible v.s. company should make device tamper proof

● Current research: Thync is safe if used by adults as intended

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Cognitive Enhancement:Education: Would the Thync device give students an unfair advantage? Does the device contribute to further widening the performance of wealthier and low-income students?

● Is It cheating if students use the Thync device on one test? For one year? What about for non-academic purposes?○ Compare to: Private tutoring, adderall

● Would it be more ethical if a school offered the device to all students?○ Counter: This would negatively affect less wealthy schools because they’re left

out1

○ Potential problem: feeling pressured to use the device

Conclusions: Devices such as the Thync device are more likely to be accepted in academia if they’re universally available.

1. http://www.theatlantic.com/education/archive/2014/07/why-poor-schools-cant-win-at-standardized-testing/374287/

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AthleticsWould an athlete using the Thync device during training or before a match be considered cheating or “doping?”

● For: Any outside influence that could give a person an unfair advantage not afforded to others should be considered doping

● Against: There’s not enough evidence that neural stimulation does anything significant to improve the performance of athletes1

1. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3620504/

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Forced Treatment:Hypothetical: Management at the LaGuardia Airport Air Traffic Control center recently told its staff that they will be required to use the Thync device at work to improve their focus. A few employees are not completely comfortable with using any stimulation devices. Is it ethical of management to impose such a requirement?

● Argument for: Employees such as air traffic controllers who are responsible for the safety of large amounts of people can reduce risk of accidents if they are more vigilant.○ It’s ok because of the benefit to society○ Is it equatable to mandatory training

● Argument against: This is a clear violation of the principle of autonomy and a person’s right to refuse intervention.○ It’s not ok because it violates the person’s rights to autonomy.

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Behavioral Manipulation:Hypotheticals:

1) Person asks their partner to put on the Thync device, claiming it’s just recording brain activity, when in reality, they are using the “Calm” vibes to stop the partner from arguing with them.a) Clearly a lie and not ethical, but is the user or manufacturer at fault?

2) Researcher asks patient to use the Thync device with brain function study as the stated goal of the study but with a goal of manipulating behavior.a) Ethicality of using these devices in studies to manipulate behavior under the

guise of brain function studiesi) For: Patients can choose their own treatmentii) Against: Based on Kantian ethics, it’s immoral to change patient behavior

as it leads to unpleasant consequences.

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Summary:Stress is a biological and psychological response experienced under certain neurological conditions.

Many neural stimulation devices have been shown to have some effect on the brain, however, the THYNC device is the first to enter a market, at a low price, and available to anyone.

The benefits to this device include being simple to use, relatively inexpensive, and enhancement promises. This has the potential to seemingly increase quality of life.

Some of the ethical concerns raised include the privacy, cognitive enhancement, use in athletics, the potential for forced treatment, and the potential for behavioral manipulation. Is ethical to put the power to do this into the hands of people who don’t understand the engineering.