Wearable tracker for Parkinson’s disease gets FDA nod

Yet another clinically-focused, activity tracking wearable has now been cleared by the FDA, this one aimed specifically at the monitoring and treatment of Parkinson’s disease. The Personal KinetiGraph, from Melbourne, Australia-based Global Kinetics Corporation, “offers comprehensive, automated reporting of a Parkinson’s disease patient’s movements so that neurologists and other

physicians can more easily identify changes in movement symptoms to assist in decisions to optimize therapy,” according to the company.

“Monitoring changes in a patient’s movement symptoms is a critical element in the treatment of Parkinson’s and many other movement disorders, but it can be difficult for both patients and healthcare providers to identify and assess changes in movement symptoms effectively,” Andrew Maxwell, managing director and CEO of Global Kinetics Corporation, said in a statement. “The Personal KinetiGraph provides clinicians with a clear and accurate assessment of the patient experience outside of office visits and examinations.” 

The wrist-worn device is already in use in Australia, but has previously not been cleared for sale in the United States. The device can be prescribed to a Parkinson’s patient by their physician; the patient then takes the device and wears it at home. It can collect and store up to 10 days of movement data. That data is then downloaded by the physician, who can use it to obtain a more accurate assessment of the patient’s mobility than they could get from an office visit.

The device can also serve as a medication adherence tool in conjunction with the Parkinson’s symptom management medication levodopa. The wearable can be set to vibrate at preset times to remind patients to take the medication.

Like most movement tracking in clinical settings, the status quo is in-lab tests and patient self-reporting, a vexing situation as Parkinson’s symptoms vary widely from patient to patient. Neurologists at the Florey Institute of Neuroscience and Mental Health in Melbourne developed the software and hardware in 2007 to try to improve the situation.

“In many cases when we discuss changes in movement symptoms with Parkinson’s patients, they are unable to recall specific information that can help doctors understand whether their disease is progressing and, if so, how rapidly,” Dr. Malcolm Horne, chief scientific officer and co-founder of Global Kinetics Corporation, who developed the technology with Dr. Robert Griffiths at the Florey Institute, said in a statement. “This technology brings clinicians a whole new level of accurate information to support more effective and timely treatment decisions.”

In February of this year, the FDA cleared two wristworn activity trackers from British company Camntech: non-smartphone-connected, but highly accurate devices intended for use in clinical trials.  In July, Australian company dorsaVi followed suit, obtaining clearance for its ViMove sensor system for detailed activity tracking. Meanwhile, Orthocare Innovations, a company that has long held FDA clearance for its StepWatch device, created a spin-off company called modus health to market their device, hitherto used mainly for research purposes, to clinicians. MobiHealthNews covered the trend in an in-depth report last month.

CDC Lists Parkinson's as the 14th Leading Cause of Death in America

Parkinson's disease is the 14th leading cause of death in the United States, according to the Centers for Disease Control and Prevention's annual analysis of mortality data.  The CDC also released data this week showing there was a 4.6% increase in deaths attributable to Parkinson's disease in 2010 (the most recent year for which they have data).  While the media is focusing on the fact that homicide has fallen off the list as a leading cause of death, here at PAN, we are focused on what we can do from a policy perspective to one day have Parkinson's no longer appear on the list.

While the CDC's mortality data is a long-standing evaluation tool, what the Parkinson's community has been fighting for is for the Centers for Disease Control and Prevention (CDC) to collect and analyze data at a much more detailed level about the incidence and prevalence of Parkinson's and other neurological diseases.  This will allow researchers to help identify populations at high risk, recognize related environmental factors, and, when coupled with scientific research breakthroughs, begin to establish prevention strategies.  This is critical work that must be done to get the research community closer to better treatments and cures.  There is legislation introduced in Congress – called theNational Neurological Diseases Surveillance System Act – to create this data collection system which PAN supports.  We also encourage people with Parkinson's to reach out to their Members of Congress to make sure they support it, too.

As our population ages, legislation such as the National Neurological Diseases Surveillance System Act – coupled with strong federal funding overall for research and supportive policies for people and families living with Parkinson's disease – becomes ever more important.  Between 500,000 and 1.5 million Americans live with Parkinson's, a disease for which there is no cure or treatment to stop the progression.

The Parkinson's Action Network is the unified voice of the Parkinson's community advocating for better treatments and a cure.  In partnership with other Parkinson's organizations and our powerful grassroots network, we educate the public and government leaders on better policies for research and an improved quality of life for people living with Parkinson's disease.  Every voice matters, and we encourage you to let yours be heard in 2012 as we continue our work in the nation's capital on behalf of the Parkinson's community.

REF: PAN

ENTACAPONE EFFICACY IN PARKINSON'S DISEASE

11th September 2014 - New research

A retrospective analysis of randomised, double-blind, placebo-controlled clinical trials of

entacapone show that it improves Parkinson's Disease symptoms but often at the expense of

dyskinesia or nausea. Entacapone is marketed as Comtan. In combination with L-dopa and

carbidopa (the active constituents of Sinemet) Entacapone is marketed as Stalevo. 

Entacapone improved daily OFF and ON times by 0.8 hours (48

minutes) compared with a placebo. People taking entacapone also did

better in the standard Parkinson's Disease symptom questionnaire the

UPDRS II, UPDRS III, and also global evaluation. Similar benefits of

entacapone were seen in subgroups of patients with and without

dopamine agonists or selegiline. Entacapone was generally well

tolerated. Dyskinesia and nausea were more frequently reported by

people taking entacapone, with 25% getting dyskinesia and 14%

getting nausea. There was no difference in reports of hallucinations.

The researchers suggest that results of this pooled analysis of entacapone clinical trials

potentially serve as a useful benchmarking data for new therapies, especially those including

L-dopa, in people with advanced Parkinson's Disease.

For more Information go to : http://www.rxlist.com/comtan-drug.htm

Complete abstract : http://www.ncbi.nlm.nih.gov/pubmed/25186800

Acta Neurologica Scandinavica [2014] Sep 3 [Epub ahead of print] 

(M.Kuoppamäki, M. Vahteristo, J.Ellmén, K.Kieburtz)

Device to help people with Parkinson's disease communicate better now available

George Patrick discusses the SpeechVive device with Jessica Huber, associate professor in Purdue's Department of Speech, Language and Hearing Sciences, and developer of the device. The device helps people with Parkinson’s disease communicate more effectively. Patrick has been using the device since 2011, and it is now available on the market through health care providers and for demonstration at many of the National Parkinson's Centers of Excellence across the United States Credit: Purdue Research Foundation

 ***** 

The device is now available to try as a demo through the National Parkinson's Disease Foundation's Centers of Excellence prior to purchasing. People who suffer from a soft voice due to Parkinson's disease can make an appointment at any of these centers: the Muhammad Ali Parkinson Center at Barrow Neurological Institute in Phoenix; the University of Florida, Gainesville, Florida; University of North Carolina, Chapel Hill, North Carolina; Struthers Parkinson's Center, Minneapolis, Minnesota; and Baylor College of Medicine, Waco, Texas.

"We are providing demo units and training at no cost to as many of the National Parkinson's Centers of Excellence as are interested in offering SpeechVive in conjunction with or as an alternative to speech therapy," said Steve Mogensen, president and CEO of SpeechVive. "We also are offering the SpeechVive units and training to professionals at Veterans Administration Medical Centers across the country. The first VAMC to offer SpeechVive is in Cincinnati, Ohio."

The SpeechVive device also is available to try at the M.D. Steer Speech and Hearing Clinic at Purdue University in West Lafayette, Indiana.

The technology was developed over the past decade by Jessica Huber, associate professor in Purdue's Department of Speech, Language and Hearing Sciences and licensed through the Purdue Office of Technology Commercialization. The focus of Huber's research is the development and testing of behavioral treatments to improve communication and quality of life in older adults and people with degenerative motor diseases.

SpeechVive reduces the speech impairments associated with Parkinson's disease, which cause people with the disease to speak in a hushed, whispery voice and to have mumbled speech. People with Parkinson's disease are commonly affected in their ability to communicate effectively.

"The clinical data we have collected over the past four years demonstrates that SpeechVive is effective in 90 percent of the people using the device," Huber said. "I am proud of the improvements in communication and quality of life demonstrated in our clinical studies. I look forward to seeing the device on the market so that more people with Parkinson's disease will have access to it."

More than 1.5 million people in the United States are diagnosed with Parkinson's disease, and it is one of the most common degenerative neurological diseases. About 89 percent of those with the disease have voice-related change affecting how loudly they speak, and at least 45 percent have speech-related change affecting how clearly they speak.

Provided by Purdue University  

Constipation in Parkinson’s Disease

www.parkinson.org Julie H. Carter, R.N., M.S., A.N.P. 

 Many people with PD have constipation. Usually it can be corrected with time, patience and dietary changes. Constipation is not failure to have a daily bowel movement. It is normal for some people to have a bowel movement every 3-4 days. The key is to know what is normal for you. Constipation is bowel movements that become more infrequent and are dry and difficult to pass.

The key to relief is patience and consistency. Constipation takes time to develop as it takes time to restore normal bowel function. Bowel training usually takes 2 to 3 months. Often you will see no change for the first week or two. Do not be discouraged; this is normal.

It is tempting to try to control bowel function with enemas or laxatives. However, these can damage the lining and function of the bowel. You should avoid them if at all possible. Some medicines, both prescription and non-prescription, cause constipation as a side effect. Have your health care provider evaluate all of your drugs.

Following is a series of steps to restore normal bowel function. Begin with STEP 1 for two weeks. If there is no significant improvement after two weeks, add to your STEP 1 routine, the items in STEP 2 and if needed, STEP 3. STEPS 4 and 5 are to be used as a temporary last resort.

  S_t_e_p_ _1_ _– _D_i_e_t_ _a_n_d_ _F_l_u_i_d_ _I_n_t_a_k_e_ _

Eat meals at the same times each day.

Include fruits, vegetables, whole grain breads and cereals in daily meals.

Drink 6 to 8 glasses (8oz each) of fluid daily. (This does not include caffeine or alcohol, which act as diuretics and can aggravate constipation.)

Drink warm liquids on rising and with breakfast. (Warm liquid and food starts bowel activity.)

Establish a relaxed, regular time of the day for bowel movements. (About 1/2 hour after a meal is best as there is normally greater bowel activity at this time.)

S_t_e_p_ _2_ _– _B_u_l_k_ _F_o_r_m_e_r_s_ _

Bulk formers can be purchased without a prescription. Examples are bran, metamucil and fibercon. They are not habit-forming.

Use bulk formers daily.

Add 1 to 2 teaspoons to bran or metamucil to your morning or evening meal each day. For fibercon, use 2 tablets per day as a starting dose.

Drink 6-8 cups of liquid daily with bulk formers. If you do not, your constipation may actually worsen.

DO NOT increase the amount of bulk former too quickly. Gas formation or stomach fullness may result.

BE PATIENT. Bulk formers may take 2 to 3 months to correct constipation.

S_t_e_p_ _3_ _– _S_t_o_o_l_ _S_o_f_t_e_n_e_r_s_ _

While working on a bowel routine, you may need to use a softener if your stools are very hard. Stool softeners, like bulk formers, are not habit-forming and may be purchased without a prescription. Examples are Colace and Surfax.

􀂅 _Use stool softener daily.

􀂅 _Begin with one a day. Increase to one each morning and evening if needed.

S_t_e_p_ _4_ _– _L_a_x_a_t_i_v_e_s_ _a_n_d_ _S_u_p_p_o_s_i_t_o_r_i_e_s_ _

                  Laxatives should be used with caution. They activate the bowel by chemical irritation. Long-term use may actually harm the bowel. Some laxatives are especially harsh, including Ex-lax, Ducolax, Feenamint, Correctal and Castor Oil. DO NOT use these while trying to establish a bowel program.

                  Relatively mild laxatives may be used while establishing a bowel program, but they are NOT a replacement for diet and bulk formers. Use them sparingly while you continue with your program. Mild laxatives that may be used are: Milk of Magnesia (2 tablespoons at night), Doxidan (1 tablet at night), Pericolace (1 tablet at night) or Senokot-S (2 tablets at night).

                  Suppositories provide rectal stimulation to empty the bowel. Stool must be present in the rectum for suppositories to be effective. Suppositories must make contact with the inside wall of the rectum to work. You may need to use suppositories while establishing a bowel program. If needed, use Glycerin daily or every other day. DO NOT use Ducolax, as it is habit-forming and irritates the bowel.

Step 5 - Enemas

                  The bowel can easily become dependent on enemas. We recommend that you use enemas only when nothing else works.

REMEMBER: CONSISTENCY AND PATIENCE ARE THE KEYS TO MANAGEMENT

OF CONSTIPATION.