Case and Commentary
Jan 2015

Applying Guidelines to Individual Patients: Deep Brain Stimulation for Early-Stage Parkinson Disease, Commentary 2

Kara Beasley, DO, MBe
Virtual Mentor. 2015;17(1):18-22. doi: 10.1001/virtualmentor.2015.17.1.ecas2-1501.


As 39-year-old Sam Ruffini sat confidently in the clinic chair, his hand tremor would have been noticeable only to a trained expert. The other signs of Parkinson disease, however, were unmistakable, such as the once-spry man’s shuffling gait. Mr. Ruffini had come to see Dr. Blue, a neurosurgeon renowned for treatment of functional nervous system disorders.

“I simply don’t want to suffer through years of trial and error with medications and their side effects. I’m a young, active guy. I can handle a surgery. If this can be improved with a one-time procedure, even if it’s brain surgery, I’d rather do that now and not wait until I’ve suffered through years of disability.”

Dr. Blue faced a dilemma. In previous years, he would have politely dismissed Mr. Ruffini and referred him back to the neurology department, since deep brain stimulation (DBS) surgery for Parkinson was still a measure of last resort for patients whose conditions had become refractory to best medical therapy. Mr. Ruffini had responded fairly well to levodopa and other standard medications for Parkinson, and he continued to function in his job as an investment banker. Although he complained about fatigue and other side effects of the medications, these did not seem to be disabling.

On the other hand, Dr. Blue had recently read about a clinical trial showing good results for patients who received DBS in the early stages of their disease, before their level of disability had progressed to the point of being “medically refractory.” He wondered if this foretold a new paradigm in thinking about proactive surgical interventions for neural disorders, including not only Parkinson but also essential tremor, depression, chronic pain, and others. In some cases, the stipulation that a patient’s condition be “medically refractory” prior to contemplation of surgery seemed to be a holdover from the era when that procedure was experimental and particularly risky. Dr. Blue’s rate of serious complications with DBS had become so low (less than 5 percent) that, depending on the patient’s preferences, he believed it could be a viable alternative to medical therapy even when the latter hadn’t failed.

When he met with the interdisciplinary DBS committee that week, Dr. Blue floated the idea of doing DBS for Mr. Ruffini. This idea was met with acrimonious objections from the neurologists and psychiatrists in the room. Based on the standard of care, they argued, Mr. Ruffini should be treated with medications, which were noninvasive and well understood, and must exhaust all reasonable nonsurgical therapies prior to being offered an invasive brain surgery.

Commentary 2

The ethical issues and treatment options that must be considered in this case can be framed by considering the interests of the involved stakeholders and what they might, potentially, have to lose. This technique was developed by Paul Ford and has shown itself extremely valuable in teaching ethical analysis to students and residents.

The Stakeholders

The clinical team. Evaluation of patients for DBS ideally occurs through a process employing a multidisciplinary team that includes neurosurgeons, neurologists, neuropsychologists, and psychiatrists. As Paul Ford and Cynthia Kubu argue, “an ongoing multidisciplinary conversation around patient selection and care provides an important avenue for establishing good practice” [1]. The first group of stakeholders we will consider are the members of the interdisciplinary team. With the exception of Dr. Blue, they are conservative in nature and have strictly applied the criterion of “medication-refractory” disease. They are not without good reasons.

Firstly, there is sound clinical reasoning for their position. Clinicians traditionally consider the ideal DBS patient to be one in whom there is a 30 percent reduction in the United Parkinson’s Disease (UPDRS) rating scale motor subsection in response to levodopa, motor fluctuations, or troubling side effects caused by medication and no significant cognitive impairment. The rationale behind the typical protocol, in which DBS is offered four to five years after onset of symptoms, is that waiting helps ensure that patients truly have idiopathic Parkinson disease (PD), rather than Parkinsonism associated with other disease entities that could be negatively affected by DBS. While DBS is not a cure, there is evidence to indicate that DBS remains effective for the motor symptoms of PD despite clinical progression [2].

Furthermore, the team’s interest in professionalism and high-quality care could also call for caution. There are strong arguments for judicious use of new technology; examples of indiscriminate use of procedures such as frontal lobotomy have colored the history of elective intracranial surgery for decades. Furthermore, invasive procedures should be offered based upon high-quality evidence, which in this case is lackluster. While there are studies that indicate that DBS is safer when used earlier in the disease [3, 4], the most compelling study only includes 30 patients.

Society and medicine. A second group of stakeholders might also have reasons for concern about offering DBS to Mr. Ruffini—society and the profession of medicine. Should Mr. Ruffini have a poor outcome, it might cost the public a great deal economically in terms of care for his complications. Poor outcomes in early uses could also hamper further adoption of the technology and hence access to DBS.

The patient. Mr. Ruffini, of course, is the other important stakeholder in this situation. His request is not unreasonable. Evidence indicates that, with the subthalamic nucleus target (STN), patients can typically reduce their medication burden by 50 percent. In their multicenter randomized trial of DBS versus best medical therapy, Weaver at al. concluded that “deep brain stimulation was more effective than best medical therapy in alleviating disability in patients with moderate to severe PD with motor complications responsive to levodopa and no significant cognitive impairment” [5]. Thus the treatment Mr. Ruffini seeks is effective for his condition and within therapeutic goals. He is a well-educated and highly functional patient who is informed about the risks, benefits, and alternatives of the procedure as well as the conventional indications. He is aware of the low complication rate of his selected surgeon, Dr. Blue, and he would elect to move forward if offered surgery.

To consider Mr. Ruffini’s interests in this situation is to consider the fact that Mr. Ruffini is the only person who can truly determine what facets of his disease and his treatment negatively affect his quality of life and whether other possibilities, like medication trials, would be overly burdensome to him. An overly paternalistic decision would obviously conflict with his self-determination and right to direct his course of care in an informed fashion. The team may correctly argue that he does not meet the established criteria and does not have the right to demand a therapy that, in their expertise, they have deemed inappropriate at this time. But such a decision, while consistent with the medical and surgical guidelines routinely practiced, could have the consequence of leaving Mr. Ruffini feeling that he had no voice in the decision making about his care.

Furthermore—perhaps most importantly—the team is making evaluations and decisions based upon outdated data and in their recommendation should take into consideration the evidence regarding earlier implantation. Two studies—Charles et al. [3] and Schuepbach et al. [4]—have provided evidence that DBS is safe for much earlier use than has been typical. In the Charles et al. study, 30 patients were randomized to optimal drug therapy (ODT) or ODT plus DBS three years earlier than is conventionally accepted. The authors concluded that DBS is “well tolerated in early PD” [3], and a larger multicenter trial has been approved. The Schuepbach et al. study randomized 251 patients with PD and early motor complications to best medical therapy or DBS plus best medical therapy. Overall, in a two-year period, the DBS plus medication group had a 26 percent improvement in quality of life and improved mobility, suggesting that “instead of waiting for patients to have very marked fluctuations, peaks and very deep valleys, [we can] move in when the peaks and valleys are not that steep” [4].

Four Possible Solutions

There are four possible solutions to this dilemma. The first would be to honor the decision of the multidisciplinary team and deny Mr. Ruffini access to DBS until he has “exhausted all reasonable medical options.” Should he choose to pursue DBS in the immediate future, he would need to do so with a different group. The second option would be for Dr. Blue to move forward with surgery based upon his medical judgment, despite the recommendations of the rest of the team. The third is for the team to agree that, while surgery will not be offered at this time, they will reevaluate the evidence and revisit the option of surgery for Mr. Ruffini in three to six months. Finally, the team could agree to consider the patient’s treatment wishes in light of the medical and scientific evidence and move forward with implantation so long as true informed consent is obtained.

Analysis of the Solutions

The first solution—to deny surgery based on the multidisciplinary team evaluation—errs on the side of paternalism and disenfranchises the patient. Each patient has a unique set of symptoms, goals for treatment, and family and social support structure. Patients should be considered holistically and not simply subjected to an impersonal checklist. Furthermore, new evidence supporting earlier utilization has emerged, calling into question the rationale behind the standard. The criterion of “medical-refractory” candidacy could allow Mr. Ruffini’s PD to jeopardize his perceived quality of life and create despair in an otherwise active and empowered patient. These consequences of withholding DBS far outweigh the risks involved in offering it.

On the other hand, it would not be advisable for Dr. Blue to disregard the recommendations of the team. This would force other team members to provide treatment they were not in agreement with; the neurologist in particular would have to oversee medication management and programming of the device. Such an action could erode future cooperation and professional trust. Strife in the team could limit access to care for other future patients, as team members may be unwilling or unable to continue a professional partnership that would benefit them.

The third solution holds some merit. It gives the team further time for discussion and review of the literature while leaving a window open for implantation in the not-so-distant future. It would ensure, and show, that the patient’s unique situation and personal autonomy are being respected without jettisoning standards of care. If the team is unwilling to move forward with the fourth and most ideal solution in this case, then consideration in the immediate future is a concession with minimal downside.

The most ethically justifiable option would be for the team to step away from strict adherence to the “medically refractory” criterion and consider the specific and individual case before them. Not every patient should be offered the surgery this early on, but the aforementioned attributes—the surgeon’s low complication rate, the new data supporting earlier utilization of the procedure, the patient’s understanding of the risks and benefits and his strong preference to intervene before his condition progresses—make a strong argument for reconsideration and recommendation to offer him surgery in this particular set of circumstances. At the end of the day, patients are people with individual circumstances, goals, and values. They should be treated as such rather than forced to conform to a predetermined set of criteria. Furthermore, as scientific evidence develops, those forming standards and guidelines should stay current and flexible, altering their criteria and evaluations as appropriate.


  1. Ford PJ, Kubu CS. Stimulating debate: ethics in a multidisciplinary functional neurosurgery committee. J Med Ethics. 2006;32(2):106-109.
  2. Krack P, Batir A, Van Blercom N, et al. Five year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson’s disease. N Engl J Med. 2003;349(20):1925-1934.
  3. Charles D, Konrad PE, Niemat JS, et al. Subthalamic nucleus deep brain stimulation in early stage Parkinson’s disease. Parkinsonism Relat Disord. 2014;20(7):731-737.
  4. Schuepbach WM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. 2013;368(7):610-622.
  5. Weaver FM, Follett K, Stern M, et al. Bilateral deep brain stimulation vs. best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009;301(1):11. Accessed December 3, 2014.


Virtual Mentor. 2015;17(1):18-22.



Conflict of Interest Disclosure

Kara Beasley is a consultant for Functional Neuromodulation Ltd. and Medtronic.

The people and events in this case are fictional. Resemblance to real events or to names of people, living or dead, is entirely coincidental. The viewpoints expressed on this site are those of the authors and do not necessarily reflect the views and policies of the AMA.