Rob McAlpine Legacy Initiative. Cutting Edge NeuroTechnologies for Improved Neurological Health: High Intensity Focused Ultrasound (HIFU) Proposal

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Austin Hodge
5 years ago
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1 Rob McAlpine Legacy Initiative Cutting Edge NeuroTechnologies for Improved Neurological Health: High Intensity Focused Ultrasound (HIFU) Proposal

2 Rob McAlpine Legacy Initiative Rob McAlpine is an outstanding individual to family, friends, business colleagues and the community. He has been a well-respected executive at Spartan Controls and is a great friend to many people in Calgary and the community. Rob has a degenerative neurological disorder known as multiple system atrophy (MSA) that is associated with the degeneration of nerve cells in specific areas of the brain. MSA impairs multiple functions or systems including blood pressure, heart rate, bladder function, and digestion. The condition shares many Parkinson s disease-like symptoms such as slowness of movement, muscle rigidity, and poor balance as well as cerebellar symptoms like impairment of movement, deterioration of speech, and difficulty swallowing. There is currently no cure as the condition progresses steadily over time and eventually is terminal. Close friends and business associates through his years of service as VP Finance and CFO at Spartan and his involvement in the Chartered Accountant profession are proposing to establish a legacy in recognition of Rob. The objective of this initiative is to help fund significant medical research initiatives of relevance to MSA and related disorders and diseases, and seek to support organizations that provide family counselling and other forms of support for those suffering from these disorders and diseases. Initially a medical research opportunity has been identified in association with the Hotchkiss Brain Institute (HBI) which involves support to acquire a highly promising piece of equipment called a High Intensity Focused Ultrasound (HIFU) unit. The legacy initiative s initial interest, which has been discussed with Rob, is to work collaboratively with the HBI to fund this unit for purchase in 2015 in honour of him. Additionally the legacy initiative hopes to establish further funds, and in further collaboration with Rob and his family, consider forming a foundation in Rob s or his family s name for longer term support of family support organizations related to MSA and related disorders and diseases, or further medical research opportunities. High Intensity Focused Ultrasound (HIFU) New technology to solve health problems Not long ago, medical imaging was limited to diagnostic X-rays, once a revolutionary tool. In a relatively short period of time, the field of imaging has exploded with new technologies like Magnetic Resonance Imaging (MRI), ultrasound, and functional MRI (fmri) enabling scientists to not only see the structure of the brain in detail but also visualize the mind as it s thinking. As our ability to understand brain processes has increased, so has our understanding of the mechanisms of disease. For example, in some cases we have been able to isolate the specific area of the brain responsible for tremors in individuals with Parkinson s and other related movement disorders. The same is true for those suffering from seizures. Armed with this knowledge, clinicians have been treating specific areas of the brain. In fact, a neurologist now at the Hotchkiss Brain Institute was the first person in the world to conclusively prove the benefit of brain surgery to successfully prevent seizures in people suffering from severe epilepsy. That research and its subsequent transfer to standards of care have improved the lives of thousands of people around the world. Page 1

3 For movement disorders like Parkinson s disease where deep brain structures are implicated, the greater challenge has been accurately approaching these structures through surgical treatment, without damaging the overlying brain tissue and blood vessels. The evolution of imaging techniques has enabled neurosurgeons to perform minimally invasive surgery via small holes drilled in the skull, an important tool in the treatment of movement disorders. Current surgical techniques can involve precise destruction of a small area of the brain or implantation of electrodes for subsequent long-term tissue stimulation, the latter known as Deep Brain Stimulation (DBS). However, these minimally invasive neurosurgeries are complex, expensive, and not without complications. Although potentially successful, patients are still faced with the terrifying decision to undertake highly invasive brain surgery to hopefully recapture their quality of life. Imagine brain surgery without a scalpel this seemingly unlikely idea is now a reality. Ushering in a new era in the treatment of neurological illness In the last twenty years, technological breakthroughs have been made in the field of high intensity focused ultrasound (HIFU), combined with the accurate guidance of MRI, that now make it possible to precisely and selectively affect the tiniest and deepest portions of the brain in an entirely noninvasive fashion. While regular ultrasound is a completely safe technology that is used routinely around the world to image inside the body, the same technology, but more focused and intense, can be used to heat and destroy tissue in an extremely precise manner for the purposes of treatment rather than just diagnosis. The idea of HIFU is comparable to using a magnifying glass to focus sunlight onto a small spot that will become very hot. Because no radiation is used and no overlying tissue is damaged, the technology is very appealing for targeting deep brain structures to treat movement disorders and other neurological conditions. MRI has also been critical to the development of HIFU-based neurosurgery, since it enables the targeted areas of the brain to be accurately identified. In its current application, a large number of ultrasound beams are focused on a target deep in the brain, and painlessly pass through the skull as an individual lies in an MRI scanner. The MRI scanner can map the brain temperature and monitor the course of the HIFU treatment in real-time while the awake patient communicates with the surgical team. The truly groundbreaking nature of HIFU-based neurosurgery the combination of ultrasound and MRI technologies to create a surgical outcome is a breakthrough with the capacity to change the way we treat a number of neurological illnesses. The illnesses with the greatest likelihood of being positively impacted by this technology are the movement disorders known as Parkinson s disease and tremor. As HIFU-based technologies are further advanced, the applications are likely to expand. Through clinical research, we envision creating opportunities to treat epilepsy, brain tumours and perhaps mental illness the potential to create improved health outcomes by merging previously independent imaging techniques is limitless and breathtaking. Page 2

4 Paving the way for new technology to improve the neurological health of our community At the University of Calgary s Hotchkiss Brain Institute, we see this emerging new technology as a high priority and we know that we have the team of scientists and physicians who will conduct the research necessary to enable the realization of its potential. Through collaborative efforts with the Departments of Clinical Neurosciences and Radiology, we will focus our cutting edge research efforts in the further development and application of HIFU-based neurosurgery to treat Parkinson s disease, as well as other neurological and psychiatric conditions. Clinical research indications now and in the future The HIFU device is an experimental system and is not currently approved by Health Canada so each and every indication will require a specific research protocol to allow us to use the device in patients. The vendor (InsighTec) will assist the University of Calgary and Alberta Health Services to secure Health Canada approved protocols. It is anticipated that the device will become FDA and Health Canada approved for specific procedures in Although the list of neurological diseases treatable by HIFU is preliminary, researchers are using this device for many conditions. It is also hoped that HIFU procedures will eventually replace other, more expensive, surgical treatments currently used. The clinical research indications under investigation for HIFU include: Essential tremor (uncontrollable shaking of the limbs of unknown cause) Tremor associated with Parkinson s disease L-DOPA induced dyskinesia (writhing movements associated with medication side-effects) Selected seizure or epilepsy conditions Trigeminal neuralgia (severe facial pain) Hemorrhagic stroke such as intra-cerebral hematomas Psychiatric disorders Enhancing chemotherapy for brain tumors Operational overview The HIFU system would be housed at the Seaman Family MR Research Centre located at the Foothills Medical Centre. The Centre represents a unique clinical research collaboration between the University of Calgary s Faculty of Medicine and Alberta Health Services. The Centre houses a powerful General Electric 3 Tesla MRI scanner that is compatible with the Insightec HIFU Unit. The HIFU unit itself surrounds the patient s head and fits inside the MRI scanner. When it is not in use, it is easily removed from the scanner and other MRI studies can be performed as normal. Page 3

5 Patients will require a pre-procedure MRI and CT scan. The latter is critical for planning HIFU procedures since the thickness of the skull along with calcium deposits in the brain must be accounted for to avoid undesired heating or poor targeting. Based on the pre-procedure CT and MRI, patients are carefully selected for their appropriateness for HIFU therapy. The workflow on the day of procedure involves the application by the neurosurgeon of a pin-based stereotactic frame around the patient s head, which is already available in Calgary. The patient will then go to the 3T MRI suite at the Seaman Family MR Research Centre. A typical case takes 3 hours but could range from 1½ to 5 hours within the scanner itself. As the technology continues to develop, case times are expected to shorten. A neurosurgeon and medical physicist or imaging expert do initial targeting based on the preprocedure scans and this is verified on the scans collected during the procedure. A medical physicist typically runs the software provided with the device. A technical representative of the company is also required on an ongoing basis until Health Canada approval is received. A movement disorder neurologist or neurosurgeon checks on the patient periodically as the lesion is being generated. An MRI technician does multiple scans during the case to monitor the treatment and then does a post-lesion MRI scan to verify the lesion. The Team The HIFU clinical research program will be a joint initiative between the HBI and the Departments of Clinical Neurosciences (Division of Neurosurgery) and Radiology. Dr. Yves Starreveld will be the lead neurosurgeon and Dr. Bruce Pike will be the lead imaging scientist. In addition to his extensive clinical training, Dr. Starreveld obtained his PhD in Medical Biophysics from Western University working on computerized methods for stereotactic functional neurosurgery. Dr. Pike is a world authority on neuroimaging research and has worked on image-guided neurosurgery for over 25 years. In addition to their academic work, Drs. Starreveld and Pike have independently created spin-off companies based on their image-guided neurosurgery research. A medical physicist specializing in high intensity focused ultrasound will also be a key member of the team. This staff scientist will have expertise in ultrasound physics, MRI-based temperature mapping, and imageguided neurosurgery methods. This individual will be 100% dedicated to this program and will be responsible for the day-to-day running of the program including establishing standard operating procedures, working with the manufacturer to obtain Health Canada and Research Ethics approval of all studies, quality assurance of equipment, running the instrument during experiments and treatments, and maintaining a comprehensive database of all treatments and outcomes. A postdoctoral fellow, jointly supervised by Drs. Starreveld and Pike, will work on specific research projects and be responsible for subject recruitment, clinical and imaging data analysis, and manuscript preparation. Page 4

6 Financials Capital equipment costs are estimated at $1.5M and an upgrade is planned for Year 6. Annual operating costs are anticipated to be $300k - $400k including maintenance contract, personnel, and scanner operating cost. Impact The implementation of this HIFU clinical research program will have a number of important benefits. First and foremost, we will introduce and develop a new treatment approach for Alberta patients suffering from movement disorders and a range of other neurological diseases. Parkinson s disease alone afflicts approximately 100,000 Canadians and new treatments are urgently needed. We believe our HIFU clinical research program will also help usher this new technology into use nationally and internationally thereby having a profound effect on the quality of life of many more patients. The HIFU program will also stimulate the research of many other HBI/UofC scientists who will bring their expertise to the program to further advance our understanding of brain health and disease. Focused ultrasound, at a much lower intensity than used for lesioning, has recently been used stimulate the brain. This capability would provide limitless possibilities for studying brain function and enormous potential for treating an even greater range of neurological and psychiatric conditions. Research in these areas will also result in significant economic benefit, as new research funding will be secured, new research trainees attracted, and new intellectual property generated. Rare is the opportunity to be on the forefront of innovation that can change lives. We are seeking community support in our endeavour to improve the health of Albertans through the application of new imaging and treatment technologies. We invite your participation in this exciting project. Page 5

7 About the Hotchkiss Brain Institute The Hotchkiss Brain Institute is a centre of excellence in neurological and mental health research and education, translating discoveries into innovative health care solutions. Connecting more than 700 researchers, doctors, clinicianscientists, trainees and staff, the HBI is working to train tomorrow s leaders in neurological and mental health research and care in an enriched environment that includes undergraduate and graduate education, and post-doctoral and postgraduate medical research programs that houses more than 300 students and fellows. The HBI is key to the University of Calgary s Eyes High vision of becoming one of Canada s top five research universities, is grounded in innovative learning and teaching and is fully integrated with the community of Calgary. About the Department of Clinical Neurosciences The Department of Clinical Neurosciences is a nationally and internationally-recognized program dedicated to advancing the health of neurological patients through innovative treatments, research, and education. The department is made up of four divisions: neurosurgery, neurology, physical medicine and rehabilitation, and translational neuroscience. Almost 100 faculty members who are physicians and scientists were recruited to Calgary from around the world to conduct and promote clinical and basic science research into diseases of the nervous system. Through the development and testing of new forms of treatment, we explore mechanisms of disease and provide subspecialized care and therapy to patients affected by diseases of the brain, spine, and nerves. About the Department of Radiology The Department of Radiology, based at the Foothills Medical Centre, leads Calgary s medical and research efforts in human imaging. Neuroimaging is a key strength of the department and is aided and elevated by state-of-the-art technology housed within the Seaman Family MR Research Centre, the Pediatric 3T Imaging Program, and the Experimental Imaging Centre. The recent recruitment of Dr. Bruce Pike to lead human brain imaging research is expanding the depth and breadth of our efforts and collaborations with the ultimate goal of improving the prevention and treatment of neurological and mental illness. For further information, please contact: Dr. Samuel Weiss Director, Hotchkiss Brain Institute 3330 Hospital Drive NW Calgary, AB T2N 4N1 T: E: weiss@ucalgary.ca Janelle Wakaruk Director, Fund Development 3330 Hospital Dr NW Calgary, AB T2N 4N1 T: E: jwakaruk@ucalgary.ca Page 6

Surgical Options. A History of Surgical Treatment. Patient selection. Essential Tremor (ET)

Surgical Options. A History of Surgical Treatment. Patient selection. Essential Tremor (ET) Essential tremor (ET) is the most common movement disorder, impacting the lives of an estimated 10 million Americans and millions more worldwide. At this time, there is no cure for ET and only about 50%