Archives: 12/2008

strokebrainpulley Exercise Machine Helps Rebuild Brain Function
Using fMRI imaging and a custom hand exercise robotic machine, Dr. A. Aria Tzika and colleagues from the NMR Surgical Laboratory at Massachusetts General Hospital have shown that chronic stroke patients, after undergoing rehabilitative exercises, were able to restore significant amount of brain function associated with the particular movement. The researchers call their robotic hand device a “second-generation prototype Magnetic Resonance Compatible Hand-Induced Robotic Device, or, MR_CHIROD.”
From the abstract presented at the annual meeting of Radiological Society of North America (RSNA):
pulley for strokes2 Exercise Machine Helps Rebuild Brain Function

METHOD AND MATERIALS
We evaluated 60 fMRI datasets at 3T from five right-hand-dominant patients (mean age: 65 years) with first-ever left-sided stroke ≥6 months prior and mild to moderate hemiparesis affecting the right hand. Patients trained the paretic hand at approximately 75% of maximum strength with an exercise ball for 1 hour/day, 3 days/week for 4 weeks. MR neuroimaging exams were performed before, during (A), upon completion of training (B), and after a non-training period (C) to assess permanence of effects. We acquired fMRI data using a block design paradigm and parallel imaging (GeneRalized Autocalibrating Partially Parallel Acquisitions, GRAPPA; TR/TE=3000ms/30ms, 1.56 mm×1.56 mm×3 mm) while the participant used the MR_CHIROD. During the action period, subjects continuously squeezed and released the MR_CHIROD at 0.5 Hz. Volunteers performed the paradigm at 45%, 60%, and 75% of maximum dynamic grip strength and could fully squeeze the device at all levels. Clusters of statistically significant voxels (P<0.05, corrected) were further selected for BOLD ≥ 2.0%. This 2.0% threshold served as a filter, selecting regions of interest without enforcing their boundaries a priori. Comparisons between effort levels were done using t-test (two-tailed, P<0.05).
RESULTS
Training significantly increased the number of activated voxels in the cortex as function of maximum effort. At 45% effort, A (mean number of activated voxels ± SD, 35 ± 15) differed from B (236 ± 32), P = 0.0022, and from C (246 ± 30), P = 0.0016. At the 60% effort, A (116 ± 31) differed significantly from B (271 ± 33), P < 0.05, and from C (271 ± 26), P < 0.05. At the 75% effort, A (180 ± 22) differed significantly from B (295 ± 38), P < 0.05, and from C (246 ± 20 voxels) P < 0.05.
CONCLUSION
Online fMRI using MR_CHIROD suggested that training-induced functional cortical plasticity persists even in chronic stroke patients indicating permanence of rehabilitation.

Top image: Left: An fMRI image illustrating the area in the brain that corresponds with a patient’s hand use before training. Effort levels are 45percent (top) and 60percent (bottom) of the patient’s maximum hand-strength. Right: An fMRI image illustrating the area in the brain that corresponds with a patient’s hand use after eight weeks of training. Effort levels are 45percent (top) and 60percent (bottom) of the patient’s maximum hand-strength. Side image: The second-generation prototype Magnetic Resonance Compatible Hand-Induced Robotic Device, or, MR_CHIROD. Credit: RSNA
Press release: Robotic Technology Improves Stroke Rehabilitation …

inflated City Wide Test of Therapeutic Hypothermia Post MINew York City paramedics are initiating a policy of delivering many of their cardiac arrest patients only to hospitals equipped with therapeutic hypothermia capabilities. As many of our readers know, there is a growing evidence of data that shows that patients with neurological sequelae after a cardiac arrest retain more neuro function if treated with mild hypothermia, even if it was initiated as long as 6 hours after arrest.
From the New York Times:

Dr. Prezant [Dr. David J. Prezant, chief medical officer of the New York Fire Department, and who coincidentally served as a consultant for Medivance, and holds stock options in the company --ed.] said that in deference to hospital finances, the city has set no requirements for the kind of cooling techniques hospitals must use — some may start with inexpensive saline solutions and plastic bags filled with ice, while others employ sophisticated equipment manufactured and aggressively promoted by companies like Alsius, Innercool Therapies and Medivance.
Under the New York protocol, patients would be eligible for cooling if they suffered cardiac arrest and regained a pulse within 30 minutes of the start of resuscitation but remained neurologically compromised. Hospitals without the ability to cool patients would be bypassed if one that did was within a 20-minute drive. Dr. Prezant said his goal is, within six months, to begin the cooling process in the ambulance, accelerating treatment.

More in the New York Times
ILCOR Advisory Statement: Therapeutic Hypothermia After Cardiac Arrest… Circulation. 2003;108:118.
Abstract: Mild Therapeutic Hypothermia to Improve the Neurologic Outcome after Cardiac Arrest N Engl J Med 346(8):549-556 February 21, 2002.
Flashbacks: Bio-compatible Ice Slurry for Ischemic Damage Control ; ThermoSuit Studied as an Adjunct Treatment for MI; The Arctic Sun®
Image: ThermoSuit from Life Recovery Systems

brain side This Is Your Brain On Placebos!The prescribing of placebos has a long and controversial history in the practice of medicine. A recent study by Dr. Ezekiel J Emanuel in the BMJ (2008;337:a1938) showed that approximately half of physicians admit to prescribing placebos.
New research has identified genetic markers in people susceptible to the placebo effect and this opens a whole new “can of worms”. Could placebo controlled studies be manipulated by selecting patients based on their response to placebos?
Check out this interesting report from Science‘s Rachel Zelkowitz about the latest efforts to understand the placebo effect…
Image: Patients with a certain copy of a serotonin gene showed less amygdala activity (left), indicating reduced anxiety, after treatment with placebos. Credit: T. Furmark et al., Journal of Neuroscience

stryker ball Shaped Titanium Implants Help Bone Growth for Better GripStryker Corp. (the most pleasant sounding name in the corporate world) is releasing a new system for hip replacement that, due to the porous nature of the proprietary Tritanium titanium matrix it is made of, helps bone tissue grow into the component.

The Tritanium technology is biologically inspired and designed to resemble trabecular bone, a type of spongy bone tissue that provides skeletal support. Unlike 2-D technology, which is the current standard of care for primary total hip replacement and allows only for bone to grow onto the component’s surface, Stryker’s 3-D Tritanium technology allows for bone to grow into the component providing enhanced fixation. Equally important, Tritanium is the only commercially-pure Titanium matrix, which studies have shown improves bone ingrowth when compared to alloys thereby offering increased biocompatibility.

More from the press release: STRYKER INTRODUCES THE FIRST AND ONLY WIDELY AVAILABLE 3-DIMENSIONAL ADVANCED FIXATION TECHNOLOGY FOR HIP REPLACEMENT (.doc)
Stryker Corp

dexcom CGM Seven Day Continuous Glucose Monitoring System Green Lighted in EU
More news from Old Europe. DexCom Inc. out of San Diego has received European approval for the company’s SEVEN® continuous glucose monitoring system. As the name implies, the system features a subdermal sensor (pictured right) that can be worn for up to seven days of continuous use. A wireless receiver plots glucose over time on a little screen, giving you a better idea of the overall trend. See the flashbacks below for four years of our continuous coverage of the device.
dexcom sensor Seven Day Continuous Glucose Monitoring System Green Lighted in EUSome of the features from the product page:

  • Only Sensor approved by the FDA for up to 7 days of use (other brands only last for up to 3 or 5 days)
  • Intuitive, easy-to-learn device buttons and functions
  • Rechargeable Receiver (other brands have batteries that require monthly replacement)
  • Large Receiver display for easy viewing
  • Water-resistant Sensor/Transmitter so that you can comfortably go about your everyday activities (no shower cover required)
  • Calibrate at any time with any FDA-cleared (U.S. commercially available) blood glucose meter
  • 24/SEVEN Low Glucose Alarm helps you sleep through the night without worrying that you might be entering the hypo zone (low glucose) without knowing
  • Press release: DexComTM Receives CE Mark Approval for the SEVEN(R) Continuous Glucose Monitoring System
    Product page: SEVEN CGM
    Flashbacks: Seven Days with DexCom SEVEN ; DexCom: Dextrose Communication; DexCom’s Continuous Glucose Monitoring System

    EU bureaucrats have issued AGA Medical, a company from Plymouth, MN, the CE Mark of Approval for the AMPLATZER Cardiac Plug, a nitinol device designed for closure or occlusion of cardiac structures not involving the septal wall, such as nonsurgical closure of the left atrial appendage in patients with atrial fibrillation.
    cardiac plug AMPLATZER Cardiac Plug Gets European OKMore about the product:

    The AMPLATZER® Cardiac Plug is designed to provide optimal occlusion with full cross-sectional orifice coverage, flexible braided Nitinol mesh, and controlled, precise deployment. The Cardiac Plug has the ability to be repositioned, if necessary.
    The lobe of the AMPLATZER Cardiac Plug is designed to conform to the inner wall of a cardiac structure with a depth of 10mm or more and provide secure device placement. Positional forgiveness is achieved through a waist that acts as an articulating, compliant connection between the disc and lobe allowing the disc to self-orient to the cardiac wall. The disc is designed to completely cover the orifice of the cardiac structure and provide apposition against the chamber wall under gentle tension…
    “The ACP is an important addition to the interventional tools we have for structural heart repair. The design and conformability of the device as well as its ease of deliverability will allow us to effectively occlude challenging anatomy such as the left atrial appendage,” said Bernhard Meier, MD, FACC, FESC, professor and chairman of cardiology, University Hospital, Bern, Switzerland. “Scientific data suggests a strong link between atrial fibrillation and formation of thrombus in the left atrial appendage, which can increase the risk of stroke to 5 percent per year. Physicians have limited options to minimize stroke risk other than anticoagulants which are often associated with adverse side effects.”
    Made of flexible braided Nitinol mesh, the ACP is designed to provide occlusion with full cross-sectional coverage. The ACP self-orients to the cardiac wall, covering the hole of the structure to be occluded. It leverages the proven microscrew technology platform used in all AGA Medical devices to provide physicians with simple, controlled and precise delivery. This allows the ACP to be recaptured and repositioned if necessary, ensuring a customized delivery and fit for each patient’s unique anatomic structure.

    Press release: AGA Medical Receives European CE Mark Approval for AMPLATZER® Cardiac Plug – Device will enable minimally-invasive transcatheter closure of cardiac structures …
    Product page: AMPLATZER® Cardiac Plug …
    Flashbacks: CE Mark Given to AMPLATZER Vascular Plug III

    547656tr Primal Pictures Wins Major Medical Education AwardPrimal Pictures, a firm out of London, England, has won an award for the finest educational entry of the year at the 34th annual Freddie Awards, but you probably know it better as the international health and medical education media awards…ahhh, didn’t think so!
    Featuring 3D interactive human anatomy, folks at Primal Pictures have developed beautiful software titles for medicine, surgery and dentistry. They have also released software demonstrating the anatomy of pilates and a title for acupuncturists.
    Here’s what the company says about its award winning 3D Head & Neck Anatomy with Special Senses and Basic Neuroanatomy software:

    Built from real human scan data, this unique software is a highly detailed and interactive teaching and learning resource used in medical establishments worldwide and instantly improves doctor-patient communication. It provides stunning and accurate 3D anatomy visuals that can be rotated 360° and viewed through 24 layers from skin through to bone.

    Beating Heart animation Primal Pictures Wins Major Medical Education Award

    The DVD-ROM includes all anatomical structures of the head, face, larynx and pharynx, ear, eyes, oral and nasal cavities, cervical plexus, brachial plexus and nine views of the brain. Hot links relate features to text, dissections, clinical slides, x-rays of pathologies, high resolution dissection stills, video clips, functional anatomy animations and surface anatomy videos that demonstrate muscle action. The British Medical Association recently awarded the DVD-ROM its Electronic Book prize.

    Primal Pictures website…
    Product page: 3D Head and Neck Anatomy with Special Senses and Basic Neuroanatomy…
    The Freddie Awards: Health Education 2008…
    More from BMJ: Head and shoulders above the rest… (BMJ 2008;337:a2830)

    ECG on keyboard Get on Board with Open Source ECG ProjectOur old pal Ivor Kovic is gathering open-source developers from around the world to engineer a generic 12-lead ECG system. The project’s goals are to start with a 3-lead ECG and work up to a 12-lead device with interpretive software for common operating systems. Further goals include adapting the system for use with mobile devices and adding features like wireless connectivity.
    Ivor says:

    The openECGproject is essentially an online community conceived around a simple, but challenging and worthy goal – to develop an open source hardware and software solution for electrocardiography. More precisely, to develop an open source, low cost, and clinically functional 12-lead PC-based ECG with interpretive software.
    The idea was conceived to help those hospitals and doctors, mainly from the Third World, who cannot afford similar currently available and expensive commercial products. Development of a free alternative could, I believe, have a profound impact on health care not just in poor countries, but in others too.
    The whole project is philanthropic and depends on the efforts of volunteers who want to make a difference. Anyone can help, so be sure to visit the site, http://www.open-ecg-project.org, promote it and recommend it to others.

    openECGproject homepage
    Image: bionerd

    analystDR Continuous ST Monitoring with AnalyST ICDSt. Jude Medical has received European approval for the company’s AnalyST implantable defibrillator, featuring continuous ST segment monitoring, a technology that can potentially lead to more timely treatment of ischemia and prevention of myocardial infarctions. Of course, the European Union did not give St. Jude the official indication for ST monitoring, because at the present time no one really knows how to use this technology for the betterment of patients, and what to do with the data. Further studies will delineate that. But it is nice to know that we are seeing new frontiers open in the monitoring of cardiac patients.
    From SJM:

    The AnalyST ICD with ST Monitoring is the industry’s first device to continuously monitor specific changes in the heart’s electrical system which can indicate conditions such as ischemia (which occurs when the flow of oxygenated blood to the heart muscle is obstructed). Changes in the ST segment also have been linked to significant clinical events such as heart attacks. Learning about these conditions earlier may lead to more timely diagnosis and therapy for patients, and possibly improve patient prognosis.
    With the device’s monitoring diagnostic, small changes in ST segment are continuously and precisely recorded and plotted, and then retrieved for the physician to review during patient follow-up visits. Because many cardiac episodes are transient in nature, continuous ST Monitoring is important because it gives physicians more comprehensive ST segment information over time rather than a sporadic, hit-or-miss diagnostic report. In the near future, physicians also will be able to monitor patients’ ST segment changes via remote transmissions from the St. Jude Medical Merlin@home transmitter (a wireless remote monitoring system in patients’ homes), and will receive alerts through the Merlin.net patient care network.
    The surface electrocardiogram (ECG) has been the gold standard for diagnosing risk for heart tissue damage and arrhythmias. However, surface ECG has limitations: it provides only a few seconds of information at a time, it cannot be used to continuously monitor the patient over a long period, and it is susceptible to poor signal quality. The AnalyST ICD not only provides continuous information, but it also provides high-fidelity electrograms from the inside of the heart for accurate detection of a wide range of ST segment changes. When combined with other data available to physicians, ST segment information helps physicians make better-informed, evidence-based decisions for patient care.
    In addition to the ST Monitoring diagnostic, the AnalyST ICD includes therapy enhancing St. Jude Medical features, such as:
    – DeFT Response(R) technology – which is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart. This enables the physician to tailor device therapy for individual patients, offering them added protection in the event of a life-threatening arrhythmia.
    – SenseAbility(R) technology – which is designed to optimize sensing to help protect against inappropriate shocks.
    – Vibrating patient notifier – The industry’s only notifier that gently vibrates – instead of issuing the standard audio alert – to notify patients if the device is not performing as designed; this can be especially beneficial for people with hearing loss.

    Press release: St. Jude Medical Announces European Approval and Initial Implant of First Device to Continuously Monitor Electrical Changes That Signal Potential Cardiac Problems …