Neoursurgery Fall 2010 by Clementine Communications

Vol. 1, No. 3

Parkinson’s patients find relief with deep brain stimulation By David VanSickle, MD, PhD Neurosurgeon, South Denver Neurosurgery

IN S I D E 3 Treating movement disorders with DBS

4 Porter rehab speeds DBS results

4 Support for

Parkinson’s patients

5 Research Briefs :: C entura Health forms statewide stroke network :: L ittleton makes national stroke honor roll :: S outh Denver Neurosurgery brings care to rural Colorado

Although deep brain stimulation was approved by the Food and Drug Administration (FDA) as an effective treatment for Parkinson’s disease in 2002, it is believed to have been used with only 6% of the eligible U.S. population to date. As successes become more widely known, patients are increasingly self-referring to a neurosurgeon, unfortunately bypassing the valuable and essential support of their treating neurologists and primary care physicians. Deep brain stimulation has been proven in multiple randomized controlled studies to be a more effective treatment for Parkinson’s disease than medical therapy alone. (See box of published studies at right.) More than 80,000 cases have been completed worldwide since 1995, according to Medtronic Inc., the sole manufacturer of the DBS device. The procedure is fully approved by the FDA

Fall 2010

Proven Results More than 80,000 Parkinson’s disease patients have been treated with deep brain stimulation since 1995. The surgery is approved by the FDA and reimbursable by Medicare and most major insurers. Numerous studies have exhibited the effectiveness of deep brain stimulation to treat Parkinson’s disease, including the following: :: Deuschl, Gunther et al. A randomized trial of deep brain stimulation for Parkinson’s disease. New England Journal of Medicine. 2006; 355: 896–908. :: Rodriguez-Oroz, M.C. et al. Bilateral deep brain stimulation in Parkinson’s disease: a multicentre study with four years followup. Brain. 2005; 128: 2,240–2,249. :: Weaver, Frances et al. Bilateral deep brain stimulation vs. best medical therapy for patients with advanced Parkinson’s disease: A randomized controlled trial. Journal of American Medical Association. 2009; 301 (1): 63–73. :: Kumar, R. et al. Double-blind evaluation of subthalamic nucleus deep brain stimulation in advanced Parkinson’s disease. Neurology. 1998; 51: 850–855.

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Deep brain stimulation approved for OCD patients By David VanSickle, MD, PhD Neurosurgeon South Denver Neurosurgery

Thanks to the success of deep brain stimulation (DBS) for patients with Parkinson’s disease, this technique is being tested with a wide variety of other According to the neurological and psychiatric conditions. National Institute of DBS is now approved for treatment of essential tremor, dystonia, and Mental Health, obsessive compulsive disorder (OCD). It also has shown promise in the approximately 2.2 million treatment of extreme, intractable depression, epilepsy, chronic pain, American adults Tourette’s syndrome, and some drug addictions. DBS for obsessive compulsive disorder is one of the newest approved experience OCD uses. The Food and Drug Administration granted a humanitarian device each year. �� continued on back cover

Deep Brain Stimulation from page 1 and reimbursable through Medicare and every major insurer. Physicians may be reluctant to refer their patients for this treatment due to misinformation, fear of adverse effects, or lack of treating neurosurgeons. In Colorado, only three locations offer this procedure. Perceived risks of this surgery also have held back widespread adoption. One of the most worrisome risk factors is infection. South Denver Neurosurgery has reduced its infection rate to 3 percent, as compared to the national infection rate of 10 percent. (Weaver, Frances et al. 2009.) One way we do this is by locating the generator under the pectoral muscle, which prevents skin erosions. We also have relocated one of the incisions from behind the ear to high on the cranium, where it is less prone to skin breakdown. Finally, we have found significant benefit in leaving cranial hair in place so that hair follicles with their attending bacteria are not disturbed. (As a side note, patients appreciate not having their heads shaved.) At South Denver Neurosurgery, we also use a combination of CT

and MRI scanning to pre-plan surgery, ensuring that we are operating around blood vessels. As a result, to date, we have experienced no hemorrhagic strokes in our first 100 DBS patients over the past three years. Illustration courtesy of Medtronic Inc.

Results Overall, DBS achieves significant results in most patients. Medication use is typically reduced by half while “on time” increases to nearly 12 hours per day from seven hours on average. (Weaver, Frances et al. 2009.) The procedure reduces the motor symptoms that characterize Parkinson’s disease, including tremors, stiffness, bradykinsesia, gait problems, and dyskinesia, allowing patients significant gains in movement and control. It also improves facial expression and posture limitations caused by the disease. DBS is not a cure for Parkinson’s disease. It also does not address nonmotor symptoms, such as depression, anxiety, balance, cognitive decline, and memory loss. In some cases, the procedures can make these issues worse or even

Major criteria for Parkinson’s DBS candidates: :: Moderate or severe idiopathic Parkinson’s disease (patients are not eligible if they have a Parkinson-plus syndrome) :: Medically intractable, having significant decline in the quality of life despite adequate medical therapy :: Experienced disease symptoms for at least five years

create them where they did not exist prior to DBS. All patients will need continued medical care after surgery with their primary care physician and/or neurologist as their disease continues to progress. This is one of the main reasons that these physicians are an integral part of the DBS process. DBS Criteria Parkinson’s disease affects approximately 1 million people in the United States, or about 1 percent of adults over the age of 55,

CASE COMPARISON Case 1

Case 2

Age: 52

Age: 72 Symptomatic: 20+ years 1 symptom: Rigidity Activity: Uses a power wheelchair and has severe contractures; requires round-the-clock care

:: No dementia

Symptomatic: 7 years

:: No diseases or medical conditions that prevent surgery

1 symptom: Dyskinesia

There is no average or ideal age for patients to receive DBS. Although patients should have exhibited symptoms for at least five years (though oftentimes only recently diagnosed), it is critical not to delay DBS treatment too long. If the disease progresses far enough to cause dementia, DBS is no longer an option. DBS will not, in general, allow for an increase in life-span, but instead will enhance the quality of life. Delaying DBS simply reduces the number of quality-of-life years. (Please see adjacent case study comparison.)

Activity: Bicycles daily; independent, but not working

After DBS • Took back racing bike from son • Spinning class three times each week

Neuroscience News | Fall 2010

• Worried that he will lose disability benefits

• Rigidity nearly resolved, revealing severe underlying contractures • Still requires wheelchair • Hopeful to stay out of nursing home

DBS Timeline

according to the Parkinson’s Disease Foundation. Although it’s no longer considered experimental, DBS is still often used only as a second- or third-line treatment, reserved for patients with relatively advanced cases of the disease and for patients whom medication alone is inadequate or can’t be adjusted precisely enough to keep their tremors and writhing under control. Approximately 10–15% of Parkinson’s patients are candidates for DBS, according to the American Association of Neurology.

Sun

Mon

Tue

Implantation of Fiducial Markers (Outpatient) 4

Surgery for Implantation of Electrodes

Three-stage Surgery At South Denver Neurosurgery, I perform DBS in a three-step process that takes approximately five weeks from start to finish. (See accompanying calendar.) The patient will need to come to the hospital on three occasions, with a total inpatient stay of one to three days and a total inpatient rehabilitation stay of one week.

Wed

30 6 7

Thu

Fri

Sat

Discharge from ICU

Rehab Surgery for Implantation of Generator

Rehab

27 28 29 30 31

Step 1

Step 2

Step 3

Implant markers (feducials) in patient skull. This procedure is a 90-minute outpatient procedure performed in the hospital. I combine CT and MRI scans to plan for the leads to be placed during the next step. Landmarks within the basal ganglion are identified to localize the lead within the subthalamic nucleus (STN). This is related to the position of the skull markers. Great care is taken with this plan to avoid blood vessels and other critical structures, thus reducing complications.

One week later, the patient returns to the hospital for surgery to implant the electrical leads in the brain. The patient is partially awake for this procedure in order to record responses. In the same procedure, we place bilateral electrodes if indicated to avoid an extra surgical step. Patients remain in the intensive care unit post-surgery, with an average hospital stay of less than two days. It is interesting to note that some patients may see a partial recovery after the electrodes have been implanted. This is due to a short-term microlesion effect and will wear off within one week.

Three weeks after electrode implantation, the patient will return to the hospital for placement of the pulse generator. Typically, the generator is placed below the epidermis in the upper quadrant of the chest, but I place these generators below the pectoral muscle to prevent skin breakdown and infection. On the day following surgery, the patient will be discharged to inpatient rehabilitation. By utilizing a rehab unit, we can typically accomplish six months of outpatient programming in about one week. This allows our patients to quickly receive the benefits of DBS.

DBS successfully treats some movement disorders In addition to treating patients with Parkinson’s disease, deep brain stimulation has been approved for use with patients suffering essential tremor (aka familial tremor) or dystonia. Research is being conducted into the use of this procedure as an effective treatment for epilepsy, chronic pain, and Tourette’s syndrome as well. Essential Tremor Essential tremor is a common hereditary condition affecting approximately 10% of the U.S. adult population. While affecting primarily the elderly, it can affect individuals of any age. Often medical therapy, such as beta blockers, is ineffective or the side effects, including lower blood pressure, are not well tolerated. When the condition impacts daily quality of life, deep brain stimulation should be considered. It’s important when evaluating quality of life that referring physicians such as primary care physicians or neurologists, consider quality of life within the context of the patient’s world. Sometimes little things such as the inability to do hobbies or fear of embarrassment from dropping a plate at a gathering can lead to social isolation with debilitating consequences. Patients with moderate to severe tremors that are medically intractable are candidates for DBS. Symptoms

as well as the treatment can be uni- or bilateral. Usually, DBS eliminates the tremor almost entirely with no visible residual benefit.

Dystonia Dystonia affects about 300,000 people in North America, including children and adults. Deep brain stimulation has been approved for use with this condition for 10 years, but has only been used with approximately 1,000 patients thus far, according to the Dystonia Medical Research Foundation. DBS may be considered for patients whose dystonia has not responded to oral medications or botulinum toxin injections (BOTOX® ), the two most common forms of therapy. Bilateral pallidal DBS produces significant benefit in dystonia with average improvements of about 50–60% in the Burke-Fahn-Marsden dystonia rating scale. Some primary generalized patients have been reported to have up to 90% improvement. DBS also has been performed on persons with secondary dystonias, cervical dystonia, segmental dystonia, and myoclonic dystonia with encouraging results. (Source: Dystonia Medical Research Foundation website [dystonia-foundation.org] accessed on Oct. 12, 2010.)

Porter rehab speeds DBS results Patients who undergo deep brain stimulation (DBS) at Porter or Littleton Adventist Hospitals with South Denver Neurosurgery may see results up to six months sooner than other patients due to the support of the inpatient acute rehabilitation unit at Porter. Porter’s rehab unit is one of the most comprehensive and elaborate in the country. In addition to a full cadre of physical, occupational, and speech therapists, the department is overseen by Medical Director Gin-Ming Hsu, MD, a physiatrist who specializes in body movement, anatomy, and physiology. The unit features Independence Square, a full-size mock town that provides patients the opportunity to test their functioning in real-world scenarios. DBS patients typically spend about a week in this unit as their final step in the DBS process before going home. During that time, specially trained staff members work with the patient, a neurologist, and the neurosurgeon to finely adjust the stimulator so that it responds to the exact needs of the patient. If this inpatient acute rehab were not available, patients would require about six months of outpatient rehab to achieve the same results, says David VanSickle, MD, PhD, a neurosurgeon with South Denver Neurosurgery.

David P. VanSickle, MD David VanSickle, MD, PhD, joined South Denver Neurosurgery in 2007. Board qualified by the American Board of Neurological Surgery, Dr. VanSickle specializes in functional neurosurgery, neuro-oncology, deep brain stimulation, and surgery for epilepsy and spinal disorders. Before pursuing his medical degree, VanSickle earned masters and doctorate degrees in bioengineering. He specialized in the design of wheelchairs, focusing on rider comfort. He went on to earn his medical degree from the University of Pittsburgh in 2001 and complete a six-year neurosurgery residency at the University of Colorado Health Sciences Center in 2007. At the University of Colorado, Dr. VanSickle was named the surgical intern of the year and later the neurosurgery resident of the year. Combining his bioengineering and neurosurgery backgrounds, he patented a new device to help facilitate epilepsy surgery. Dr. VanSickle has authored and co-authored numerous peer-reviewed journal articles and has given multiple presentations at the Neurosurgery in the Rockies conferences. He is a member of the American Association of Neurological Surgeons, Congress of Neurological Surgeons, and the American Medical Association. He also is on the board of directors of the Parkinson Association of the Rockies.

To learn more about the Porter rehabilitation unit, please go to porterhospital.org/rehab or call Anne Goetz, RN, MSN, Porter’s director of physical medicine and rehabilitation, at 303-765-3599.

Dr. VanSickle’s current research and clinical interests include: :: W orking to improve the risk/benefit ratio of deep brain stimulation surgery :: D eveloping more effective biomedical devices

Parkinson’s Support Parkinson’s disease affects nearly 17,000 people in the Rocky Mountain Region. The Parkinson Association of the Rockies helps these people and their families understand and cope better with the disease. The organization serves Parkinson patients throughout Colorado, Wyoming, and western Nebraska, providing programs, support, and services such as case managers and specialized equipment. The organization is nonprofit and depends on contributions and fundraisers to accomplish its work. To learn more and help support the organization, please go to parkinsonrockies.org. A calendar of events and support group meetings is provided.

Dr. VanSickle is married with one son and one daughter. He enjoys reading ancient history as well as travel, diving, and many of the outdoor activities of the Rocky Mountain region.

Neuroscience News

research briefs

Centura Health forms statewide stroke network Littleton Adventist Hospital, an acute primary stroke center with comprehensive capabilities, is a hub in a new statewide stroke program launched by its parent organization, Centura Health. Christopher Nichols, MD, who specializes in endovascular surgical neuroradiology and vascular neurology with South Denver Neurosurgery at Littleton Hospital, is a key treating neurologist in the program. The Centura Health Stroke Network of Care connects statewide EMS partners, Flight For Life Colorado® air and ground transport teams with Centura’s six Comprehensive or Acute Primary Stroke Centers to expedite life-saving care in the most crucial first moments of a stroke. Littleton Hospital was one of the first providers in Colorado to be designated a Primary Stroke Center by the Joint Commission in 2005. It received the Gold Performance Award from the American

South Denver Neurosurgery brings care to rural Colorado

Littleton makes national honor roll Littleton Adventist Hospital’s stroke program has been named to the Target Stroke Honor Roll by the American Heart Association/American Stroke Association. Only five hospitals across the nation made the honor roll for this new initiative and earned recognition from AHA/ASA, with Littleton Hospital being the only Colorado hospital to make the list. The criteria for Target Stroke is to give IV TPA within 60 minutes to patients more than 50% of the time for one quarter.

Stroke Association for its adherence to Get With the Guidelines in 2010. For more information about neuroscience and stroke services at Littleton Hospital, go to mylittletonhospital.org/stroke or call the hospital’s stroke coordinator, Janet Carlson, at 303-734-8694.

SDN Physicians Dr. Guiot is now seeing new patients at Castle Rock Adventist Health Campus 8:30 a.m.–noon every Monday.

Littleton Adventist Hospital’s Ben Guiot, MD, a neurosurgeon specializing in spine care with South Denver Neurosurgery, is one of 13 specialists participating in a state-of-the-art telehealth program to bring care to residents in rural Colorado. The program, Connected Care, is a partnership between Centura Health and UnitedHealthCare, in collaboration with the state of Colorado. Connected Care currently serves patients in Lamar, Leadville, Buena Vista, and Del Norte where access to specialists is limited. The program uses sophisticated high-definition video technology to deliver a telehealth experience similar to an in-person visit with a doctor. “There are many regions of the state, the country, and even the world that can’t support the presence of full-time specialists, yet these people are no less deserving of quality health care than those living in urban areas,” Guiot says.

Ben Guiot, MD Neurosurgeon, board certified by the American Board of Neurological Surgeons, specializing in all aspects of spine care, including minimally invasive spine surgery, spinal deformity correction, and reconstruction of complex spinal disorders.

Christopher Nichols, MD Neurologist specializing in stroke and vascular neurology and endovascular neurosurgery, including evaluation and treatment of brain aneurysms, acute stroke, and cervical arterial disease.

J. Adair Prall, MD Neurosurgeon specializing in trigeminal neuralgia, spinal disorders, neuro-oncology, and stereotactic radiosurgery (Gamma Knife and CyberKnife).

For more information on this program, go to centura.org or email Bob Wallace, rural health service line director for Centura Health, at bobwallace@centura.org.

David VanSickle, MD, PhD Neurosurgeon specializing in deep brain stimulation, epilepsy surgery, neuro-oncology, and spinal disorders.

Neuroscience News | Fall 2010

About Us South Denver Neurosurgery provides state-ofthe-art diagnostic and treatment programs for a wide range of brain and spinal disorders. We partner with our patients and their physician teams to make individualized decisions and treatment plans. Our physicians are some of the most experienced in the Rocky Mountain region, offering the latest, most up-to-date procedures and treatment options to patients.

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Physicians desiring a consult, please call: 303.734.8650 Locations: Littleton Adventist Hospital Campus Arapahoe Medical Plaza III 7780 S. Broadway, Suite 350 Littleton, CO 80122 Porter Adventist Hospital Campus Harvard Park Medical Plaza 950 E. Harvard Ave., Suite 620 Denver, CO 80210 Castle Rock Adventist Health Campus 1189 S. Perry St., Suite 230 Castle Rock, CO 80104 South Denver Neurosurgery 303.734.8650 (phone) 303.734.8653 (fax) www.SouthDenverNeurosurgery.org

Deep brain stimulation for OCD from page 1 exemption (HDE) for this use in February 2009. Due in large part to the comprehensive behavioral health program at Porter Adventist Hospital, South Denver Neurosurgery is the first practice in Colorado to begin offering DBS for these patients. The FDA based its approval on a review of data from 26 patients with severe treatment-resistant OCD who underwent the deep brain stimulation at four sites. On average, patients had a 40 percent reduction in their symptoms after 12 months of therapy. (Source: U.S. Food and Drug Administration news release: Feb. 19, 2009. fda.gov.) OCD patients who are candidates for With OCD, it’s believed that hyperactive brain circuitry in the DBS meet these criteria: nucleus accumbens region contributes to heightened anxiety and, :: I ntractable OCD: Patients must have tried often, depression. People with the disorder indulge in repetitive and failed at least three medications, behaviors—such as washing their hands incessantly or repeatedly including Clorazil. making sure a door is shut—as a way of controlling anxiety. :: S evere level of dysfunction: Patients must Stimulating that region of the brain appears to inhibit circuits score in the severe or extreme categories that are overactive, which results in reduced anxiety and allows the on the Yale-Brown Obsessive Compulsive patients to discontinue or reduce the repetitive behavior. Scale (Y-BOCS) test. Because DBS for OCD was given only HDE approval, its marketing is limited to 4,000 patients annually. This is the first time deep brain stimulation has been approved as a therapy for a psychological disorder. Current research is showing promising results for the use of DBS to relieve severe depression and drug addiction.

Centura Health complies with the Civil Rights Act of 1964 and Section 504 of the Rehabilitation Act of 1973, and no person shall be excluded from participation in, be denied benefits of, or otherwise be subjected to discrimination in the provision of any care or service on the grounds of race, religion, color, sex, national origin, sexual preference, ancestry, age, familial status, disability or handicap.