Q&A: Ethical decision-making around neurotechnology treatments

(Press-News.org) UNIVERSITY PARK, Pa. — A novel neurotechnology treatment known as deep brain stimulation (DBS) can benefit patients with neurological disorders, but it involves surgical procedures with potential risks. Assessing the risk-benefit tradeoffs and the ethics in making decisions about whether to begin such treatments and when can be tricky for both patients and clinicians.  

Laura Cabrera, associate professor of engineering science and mechanics, received a four-year, $1.5 million grant from the National Institutes of Health to research and develop a patient-centered decision aid to help guide patients, providers and caregivers navigating their options.  

In a Q&A with Penn State News, Cabrera, who also is the Dorothy Foehr Huck and J. Lloyd Huck Chair in Neuroethics, a senior research associate in the Rock Ethics Institute and an associate professor of philosophy, discussed her plans for the research.  

Q: What is deep brain stimulation, and what conditions does it treat?  

Cabrera: DBS is a neurotechnology that involves the surgical implantation of an electrode or electrodes in the brain and the implantation of a pulse generator — sometimes called a “brain pacemaker” — under the patient’s clavicle or in the abdomen. The pulse generator, which controls the settings of the brain implant, such as voltage and frequency, is carefully programmed to deliver electrical impulses to specific targers in the brain to modulate brain activity.  

DBS is currently approved for patients suffering from a variety of movement disorders, including Parkinson’s disease and essential tremor, as well as for patients with treatment-resistant obsessive compulsive disorder. There are a growing number of clinical trials to see if DBS can also help with other neurological and psychiatric conditions. 

Q: What are the potential benefits or drawbacks for using the treatment early in a disease’s progression?  

Cabrera: We know that different patients have different values and preferences regarding their health care; some will opt for an advanced neurotechnology early in the disease progression, while others will wait until they have exhausted other mechanisms. Potential benefits include reduced medication use and less surgical risks, which increase with age. Some studies claim even reduced costs to patients and the potential to be disease modifying. However, there also are important drawbacks, including the potential to be misdiagnosed and cumulative operative risks that come with living more years with implanted hardware. Early use of DBS has the possibility of increased life expectancy, which exposes patients to more disease complications not addressed by the intervention. 

Q: What are some ethical concerns to consider when deciding whether or when to use neurotechnology? 

Cabrera: Key ethical concerns are related to informed consent. The use of advanced neurotechnologies is a value-laden, preference-sensitive medical decision due to the complex trade-offs and burdens associated with them. Aside from costs, which might include surgery, devices, anesthesia, and hospital and physician fees, some additional decision-making considerations include quality of life, convenience, timing of intervention, limitations and changes in the activities of daily living, long-term outcomes, as well as additional decision-making considerations will be identified in this research. As such, having a mechanism to assess patients’ understanding of these considerations and alignment with expectations is key.  

Q: How do you plan to help clinicians, patients and caregivers make decisions on whether to pursue advanced treatments involving neurotechnology?  

Cabrera: A relevant approach to decision making is a process called shared decision making, in which physicians and patients arrive at a treatment plan together after considering patients’ individual values, preferences and goals. This process is enhanced by patient decision aids, which are used to support patient participation in the decision-making process and increase the likelihood of reaching a treatment decision that is not only clinically sound, but also in line with a patient’s values and preferences.  

Through the course of this grant, we will develop a patient-centered decision aid to help patients and their clinicians engage in meaningful shared decision making around the early use of DBS for Parkinson’s disease. We hope that by having a tool that helps patients, caregivers and clinicians collaborate more effectively in the decision-making process, identifying the values and preferences each patient has regarding their health care needs, would allow them to identify the most appropriate time for a given patient to pursue this type of treatment. 

The outcomes of this research can also help anticipate important future ethical issues and foster the responsible use of neurotechnologies early in the disease progression for a variety of brain related disorders.   

Q: Who are the other collaborators on this grant and what professional experience do they bring?  

Cabrera: Jennifer Blumenthal-Barby, a professor of medical ethics at Baylor University, has experience and expertise in neuroethics and developing decision aids, and was a member of the research team that updated the International Patient Decision Aid Standards framework and criteria in 2012. Sol De Jesus, assistant professor and associate vice chair for quality in the Penn State College of Medicine’s Neuroscience Institute, has focused on clinical translational work in patients with movement disorders. De Jesus leads the Penn State DBS clinic and utilizes DBS in her practice. Benjamin Levi, professor of pediatrics in the Penn State College of Medicine, has focused his bioethics research on the creation of creating online decisional tools.  

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