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I copy news articles pertaining to research, news and information for Parkinson's disease, Dementia, the Brain, Depression and Parkinson's with Dystonia. I also post about Fundraising for Parkinson's disease and events. I try to be up-to-date as possible. I have Parkinson's diseases as well and thought it would be nice to have a place where updated news is in one place. That is why I began this blog.
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Saturday, June 13, 2015
The Brio Neurostimulation System is "an implantable deep brain stimulation device to help reduce the symptoms of Parkinson's disease and essential tremor, a movement disorder that is one of the most common causes of tremors," the FDA said in a news release.
FRIDAY June 12, 2015, 2015 -- The U.S. Food and Drug Administration on Friday approved a device that can be implanted into the brain to help people battling Parkinson's disease.The agency estimates that about 50,000 Americans are diagnosed with Parkinson's annually, while essential tremor affects "several million" people, most over the age of 40.
"There are no cures for Parkinson's disease or essential tremor, but finding better ways to manage symptoms is essential for ," Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological , said in the news release.
"This new device adds to the array of treatment options to help people living with Parkinson's and essential tremor enjoy better, more productive lives," he said.
The device is consists of a small, rechargeable battery-powered "pulse generator" implanted under the skin. Wire leads from the generator lead to specific brain locations, depending on the under treatment. People trained in using the devices can adjust the pulse generator's effects as needed, the FDA said.
The Brio Neurostimulation System was approved based on the results of two clinical trials, one involving 136 patients with Parkinson's disease who used the device for three months, and another involving 127 patients with essential tremor who used it for six months. In both studies, medications had already failed to control patients' symptoms, the FDA said.
"Both groups showed statistically significant on their primary effectiveness endpoint when the device was turned on, compared to when it was turned off," the agency said.
The device does not come without risk, including intracranial bleeding which can lead to stroke, paralysis or death, the FDA said. Infection and device dislocation are also potential risks.
"Brio Neurostimulation System is the second device approved by the FDA for Parkinson's and essential tremor," the agency said. "The first device, Medtronic's Activa Deep Brain Stimulation Therapy System, was approved in 1997 for tremor associated with essential tremor and Parkinson's disease. In 2002, the indications were expanded to include the symptoms of Parkinson's disease."
AbbVie to Present Data from Studies of DUOPA® (carbidopa and levodopa) Enteral Suspension in Advanced Parkinson's Disease
AbbVie to Present Data from Studies of DUOPA®
(carbidopa and levodopa) Enteral Suspension
in Advanced Parkinson's Disease During the
International Congress of Parkinson's Disease
and Movement Disorders
- AbbVie's commitment to advanced Parkinson's disease showcased with seven accepted abstracts
NORTH CHICAGO, Ill., June 12, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced it will present data from studies of DUOPA® (carbidopa and levodopa) enteral suspension in patients with advanced Parkinson's disease during the 19th International Congress of Parkinson's Disease and Movement Disorders in San Diego.
"Our continued study of advanced Parkinson's disease demonstrates AbbVie's dedication to make a remarkable impact for patients affected by this devastating disease," said Michael Robinson, M.D., vice president, medical affairs, AbbVie. "AbbVie is committed to ongoing research in this important area of medicine."
Presentations of AbbVie's studies of DUOPA include:
- Effects of levodopa-carbidopa intestinal gel on non-motor symptoms and safety of outpatient titration: a new phase 3 study in patients with advanced Parkinson's disease; Standaert, DG, et al.; Poster Presentation #327; Monday, June 15, 2015; 12:30-2 p.m. PT
- Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Less than 10 Years of Parkinson's Disease – Interim Results from the GLORIA Long-term Registry; Antonini, A, et al.; Poster Presentation #175; Monday, June 15, 2015; 12:30-2 p.m. PT
- Global Long-term Registry on Efficacy and Safety of Levodopa-Carbidopa Intestinal Gel in Patients with Advanced Parkinson's Disease in Routine Care (GLORIA) – Interim Results in a Subgroup of Patients with Dyskinesia at Baseline; Poewe, W, et al.; Poster Presentation #295; Monday, June 15, 2015; 12:30-2 p.m. PT
- Interim results of outpatient levodopa-carbidopa intestinal gel titration in patients with advanced Parkinson's disease; Rodriguez, R, et al.; Poster Presentation #301; Monday, June 15, 2015; 12:30-2 p.m. PT
- Role of clinical nurse educators (CNEs) in levodopa-carbidopa intestinal gel (LCIG) clinical studies in Parkinson's disease (PD); Olson, E, et al.; Poster Presentation #282; Monday, June 15, 2015; 12:30-2 p.m. PT
- Updated long-term safety from ongoing phase 3 trials of levodopa-carbidopa intestinal gel in patients with advanced Parkinson's disease; Rodriguez, R, et al.; Poster Presentation #302; Monday, June 15, 2015; 12:30-2 p.m. PT; Guided Poster Tour #302; Wednesday, June 17, 2015; 12-1:30 p.m. PT
- Effect of levodopa-carbidopa intestinal gel on resting tremor in patients with advanced Parkinson's disease; Fernandez, H, et al.; Poster Presentation #218; Monday, June 15, 2015; 12:30-2 p.m. PT
Levodopa-carbidopa intestinal gel is marketed by AbbVie as DUODOPA® (levodopa-carbidopa intestinal gel) outside the United States.
About DUOPA® (carbidopa and levodopa) enteral suspension
DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease.
Important Safety Information
DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.
Because DUOPA is administered using a PEG-J or naso-jejunal tube, gastrointestinal complications can occur, including bezoar; ileus; implant site erosion/ulcer; intestinal hemorrhage, ischemia, obstruction, or perforation; pancreatitis; peritonitis; pneumoperitoneum; and wound infection, any of which may require surgery or be fatal. Instruct patients to immediately report abdominal pain, prolonged constipation, nausea, vomiting, fever, or melanotic stool.
Patients treated with levodopa (a component of DUOPA) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed they were alert immediately prior to the event. For this reason, prescribers should reassess patients for drowsiness or sleepiness in DUOPA-treated patients, especially since some of the events occur well after the start of treatment. Advise patients about the potential to develop drowsiness with DUOPA and ask about factors that may increase risk of somnolence. Consider discontinuing DUOPA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation. For these patients, if a decision is made to continue DUOPA, advise them to avoid driving and other potentially dangerous activities that might result in harm if the patients become somnolent.
Monitor patients for orthostatic hypotension, especially after starting DUOPA or increasing the dose.
There is an increased risk for hallucinations, psychosis, and confusion in patients taking DUOPA. Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of levodopa. Patients with a major psychotic disorder should not be treated with DUOPA.
Patients may experience intense urges while on DUOPA. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while on DUOPA. Consider reducing the dose or discontinuing DUOPA if a patient develops such urges.
Depression has been reported in patients treated with DUOPA. Monitor patients for depression and concomitant suicidal tendencies.
Withdrawal-emergent hyperpyrexia and confusion, a symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal, or change in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction of DUOPA.
DUOPA may cause or exacerbate dyskinesias, which may require a dose reduction of DUOPA or other Parkinson's disease medications.
Generalized polyneuropathy has been reported in patients receiving DUOPA. Assess patients for the signs and symptoms of peripheral neuropathy before and periodically after starting DUOPA, especially patients with pre-existing neuropathy, patients taking medications, or those who have medical conditions associated with neuropathy.
Myocardial infarction and arrhythmia were reported in patients taking carbidopa-levodopa. Ask patients about symptoms of ischemic heart disease and arrhythmia, especially those with a history of myocardial infarction or cardiac arrhythmias.
Parkinson's disease patients have a higher risk of developing melanoma than the general population and should be monitored periodically for melanoma.
DUOPA may increase the risk for elevated blood urea nitrogen (BUN) and creatine phosphokinase (CPK). Patients taking levodopa may have increased levels of catecholamines and their metabolites in plasma and urine, giving false positive results that suggest the diagnosis of pheochromocytoma.
Monitor patients with glaucoma after starting DUOPA, as it may cause increased intraocular pressure.
Drug Interactions: Monitor patients taking selective MAO-B inhibitors and carbidopa-levodopa for orthostatic hypotension. Concurrent administration with antihypertensives may result in postural hypotension, necessitating a dose reduction of the antihypertensive. Co-administration with dopamine D2 antagonists, isoniazid, or iron salts may reduce effectiveness of DUOPA.
The most common adverse events for DUOPA, with an incidence at least 7% greater than oral carbidopa-levodopa immediate release (CLIR), were (DUOPA vs. CLIR): complication of device insertion (57% vs 44%), nausea (30% vs 21%), depression (11% vs 3%), peripheral edema (8% vs 0%), hypertension (8% vs 0%), upper respiratory tract infection (8% vs 0%), oropharyngeal pain (8% vs 0%), atelectasis (8% vs 0%), and incision site erythema (19% vs 12%).
Full Prescribing Information, including the Medication Guide can be found at www.rxabbvie.com.
Friday, June 12, 2015
Video shown on first page
Published on June 12, 2015 at 6:08 AM
Parkinson's disease patients whose symptoms such as tremor, muscle stiffness and slowed movement make it tough to hold an eating utensil steady have few options for relief outside of a hospital or clinic. Medication can help, but over time it tends to become less effective.
To give these patients another in-home option, Johns Hopkins graduate students have invented a headband-shaped device to deliver noninvasive brain stimulation to help tamp down the symptoms.
The students' prototype, developed during a yearlong biomedical engineering master's degree program, has not yet been tested on humans, but it is viewed as a promising first step toward helping Parkinson's patients safely relieve their own symptoms at home or elsewhere without going to a hospital or doctor's office.
The design has already received recognition at several prominent competitions. On June 9, it won the $5,000 second-place prize in VentureWell's BMEidea national design contest for biomedical and bioengineering students. In May, the invention earned first-place honors in the People's Choice Award competition at Johns Hopkins' Biomedical Engineering Design Day 2015. Earlier, it was a finalist in the Rice University Business Plan Competition.
The five student team members were inspired to build the new device last summer after observing neurosurgery being performed on Parkinson's patients at the Johns Hopkins Hospital. Parkinson's is an incurable neurodegenerative disorder that affects 1 million people in the United States and 7 million worldwide.
For patients in advanced stages, one treatment option is deep brain stimulation. In this procedure, a surgeon implants thin electrical leads into the region of the brain that controls movement. The leads are connected to a pulse generator—similar to a pacemaker for the heart—that is placed under the skin below the collarbone. This implant sends electrical signals to the brain to help curb some symptoms caused by Parkinson's.
"We saw that this procedure is really invasive and can take 10 to 15 hours to complete," said Shruthi Rajan, a team member from Charlotte, N.C. "It's also very expensive, and not all patients qualify for the surgery. We asked if there was a way to provide the same treatment in a less invasive way that doesn't require brain surgery."
The students were referred to Yousef Salimpour, a Johns Hopkins Medicine postdoctoral research associate who has been studying a noninvasive Parkinson's therapy called transcranial direct current stimulation. In this painless treatment, low-level current is passed through two electrodes placed over the head to tweak the electrical activity in specific areas of the brain. The technique can be used to excite or inhibit these nerve cells. The treatment is still considered experimental, but it has attracted much attention because it does not require surgery and is inexpensive, safe and relatively easy to administer without any side effects.
The biomedical engineering students met with Salimpour to learn about the research he conducts in a clinical setting. "We told him we had an idea for a portable home version of this equipment," Rajan said. "But we planned to add safety measures to make sure the patient used it properly without a doctor or nurse being present."
The students aimed for a prototype that would enable a patient to activate the battery-powered treatment by touching a large easy-to-press button. With patient safety in mind, the students designed their prototype to deliver current for only 20 minutes daily and only at a doctor-prescribed level.
To help fine-tune their design, the students met with dozens of Parkinson's patients over a four-month period. Although the students did not administer the actual brain treatment, the patients helped them craft the critical headband component so that it would be easy to put on, comfortable to wear and positioned so that the electrodes would remain stable and properly target the motor cortices areas of the brain.
"For a comfortable fit, we put an elastic band in the back and told the patients to put it on like a baseball cap," said team member Ian Graham of Old Saybrook, Conn. "The interaction with the patients was really helpful. In our usual college classes, we're just given a textbook problem to solve. In this program, being able to find a real-life biomedical problem and figure out how to address it was huge. And we even received letters of encouragement from some of the patients we met."
The other members of the student design team were David Blumenstyk, Erin Reisfeld and Melody Tan.
In addition to the assistance from neuroengineer Salimpour, the student inventors received guidance from other members of an interdisciplinary team of Johns Hopkins medical researchers that includes neurologist Zoltan Mari, neurosurgeon William Anderson and neuroscientist Reza Shadmehr.
"Our group is working on the idea of using noninvasive brain stimulation for Parkinson's disease symptom control as a new clinical treatment," Salimpour said. "Our preliminary results were promising. Patients keep asking us for more of this treatment. But we couldn't provide the treatment for them because there is no portable and FDA-approved device like this for Parkinson's patients that is on the market at this time. The biomedical engineering students then approached us with the idea of designing the home-based treatment device. They did a great job, and made a fascinating prototype. We hope that based on their preliminary work, Parkinson's patients will receive the benefit of this new technique at home very soon."
With help from the Johns Hopkins Technology Ventures staff, the student inventors obtained provisional patents covering the design of the device, dubbed the STIMband. Another Johns Hopkins student team is slated to take over the project in September to further enhance the design and move it closer to patient availability. One addition may be a wireless connection to allow a doctor to adjust a home patient's treatment level from a remote location.
The STIMband project and other undergraduate and graduate-level student inventions are a hallmark of the Johns Hopkins Department of Biomedical Engineering, which is shared by the university's Whiting School of Engineering and its School of Medicine. Students work on these projects within the department's Center for Bioengineering Innovation and Design.
BME grads develops noninvasive deep brain stimulator to control Parkinson’s symptoms