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Friday, September 13, 2013

2013 MS Symposium in Miami - Register to listen to this Live UPSTREAM Webcast

Click the Flyer to make larger.

Click to register to attend


Thursday, September 12, 2013


Tips for staying cool this summer

With summer coming up, don’t forget to register for the electricity rebates if you are eligible – both rebates require applicants to be holders of Concession or Health Care cards among other eligibility requirements.

Queensland Government – click here (remember to apply every two years. Currently provides $282.54 per year rebate)
Australian government – click here (annual $143.00)

See our tips for keeping cool by clicking here.

The National Health Directory

The website is now available via a free iPhone or Android phone app. It provides addresses, opening times and phone numbers of 14,000 GP clinics, pharmacies, emergency departments and hospitals in towns and cities across Australia. For more information click here.

MS International Federation – World Atlas of MS Database has been updated

For the first time, information and data on the epidemiology of MS and the availability and accessibility of resources to diagnose, inform, treat, support, manage and rehabilitate people with MS worldwide are available in one database for analysis and comparison at country, regional, and global levels. For more information click here.

World Report on disability

The first ever world report on disability, produced jointly by World Health Organisation and the World Bank, suggests that more than a billion people in the world today experience disability. For more information click here.


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Wednesday, September 11, 2013

Sept 10, 2013 - : "ENDECE Neural’s NDC-1308 Induces Remyelination in Models of Multiple Sclerosis (MS)

ENDECE Neural’s NDC-1308 Induces Remyelination in Models of Multiple Sclerosis (MS)
Maturation of Myelin-producing Cells Described in Presentation at CNS Diseases World Summit

Mequon, Wisc., September 10, 2013 –  Scientists from ENDECE Neural presented preclinical data this week showing that the company’s lead compound, NDC-1308, can address one of the root causes of multiple sclerosis (MS) by inducing remyelination (restoration of the lost myelin sheath in nerves that have been damaged by MS). The results, which were presented at the CNS Diseases World Summit 2013 in Boston, suggest that NDC-1308 can induce remyelination in an animal model of demyelination, in which the neurotoxicant cuprizone was used to remove the myelin sheath from the axons (nerve fibers) of mice.

According to the researchers, NDC-1308 induces differentiation of oligodendrocyte progenitor cells (OPCs) into mature oligodendrocytes (cells that synthesize and maintain the myelin sheath that covers nerves in the brain and spinal cord). “For decades, researchers have been seeking ways to induce remyelination in diseases such as MS that are characterized by demyelination,” noted James G. Yarger, Ph.D., chief executive officer and co-founder of ENDECE Neural. “Observations that pregnant women typically do not experience the symptoms of MS during the third trimester have led researchers to investigate various forms of synthetic estrogen for the treatment of MS. Our research shows that the estradiol analog NDC-1308 can induce remyelination in demyelinated axons in a cuprizone animal model of demyelination.”

In their poster presentation, Dr. Yarger and colleagues described how they synthesized more than 40 proprietary estradiol analogs in which the core structure of estradiol had been modified, and assessed how those modifications changed the hormone’s biological activity. NDC-1308 was identified as the most potent of several proprietary analogs having the ability to directly induce differentiation of OPCs into mature oligodendrocytes. By contrast, the female hormones estradiol and estriol do not exhibit that activity.NDC-1308 derives its novel activity from the addition of an alkoxyalklyl moiety to the C-6 position on the estradiol B-ring. The investigators reported the following findings:
·         In a cuprizone mouse model of demyelination, a 2-week course of NDC-1308 (50 mg/Kg once daily) was associated with a 20% increase in remyelination of hippocampal regions of the brain (P<0.01) in proof-of-concept studies.
·         Consistent with the mouse cuprizone data, NDC-1308 enhanced remyelination in demyelinated rat brain slices in culture visualized by staining for myelin basic protein.
·         NDC-1308 induced isolated OPCs to differentiate into mature oligodendrocytes in culture, whereas estriol and estradiol did not (P<0.01).
·         NDC-1308 caused a dramatic upregulation of genes (5- to 75-fold) in signaling pathways involved in OPC differentiation and myelin sheath production.
“While NDC-1308 is structurally similar to estradiol and estriol, it differs from those two female hormones in that it potently promotes remyelination by inducing OPC differentiation and maturation of oligodendrocytes at the sites of demyelination,” explained co-investigator Bruce D. Trapp, Ph.D., who is chair of the Department of Neurosciences at the Lerner Research Institute at the Cleveland Clinic. “NDC-1308 induces significant remyelination of axons in the demyelination model in mice.”

“There is a large market opportunity for NDC-1308, as no commercially available drug is capable of directly restoring the lost myelin sheath on damaged axons in patients with MS,” added Dr. Yarger. “We envision NDC-1308 being administered either alone or in combination with current therapeutics that target the immune response and/or inflammation associated with MS. By inducing remyelination, it may be possible to restore muscle control, mobility, and cognition in patients with MS. Therefore, a drug that induces remyelination, such as NDC-1308, can potentially double the size of the current market for MS therapeutics.”

About NDC-1308
NDC-1308 is a novel chemical entity designed to address one of the root causes of MS, and is being developed for potential use either alone or in combination with other MS therapeutics that slow the progression of the disease. By controlling key genes in pathways leading to myelin synthesis, NDC-1308 appears to induce restoration of the lost myelin sheath that is believed to cause the devastating symptoms of MS. NDC-1308 is a small molecule that readily crosses the blood-brain barrier, allowing it to reach the tissues in the brain and spinal cord where promoting myelin production is needed. ENDECE Neural discovered NDC-1308 in-house, and owns the intellectual property surrounding the compound.

About ENDECE Neural
ENDECE Neural is a private biotechnology company at the forefront of developing therapies to repair and potentially reverse damage caused by devastating neurological diseases such as multiple sclerosis (MS). A wholly owned subsidiary of ENDECE LLC, ENDECE Neural was founded in 2011 to focus on the development of what could be the first drug capable of inducing remyelination of damaged nerves in patients with MS. The company is leveraging decades of accumulated knowledge about how activation of estrogen receptors in a specific manner affects gene regulation. Researchers at ENDECE Neural have identified small-molecule compounds that upregulate key genes in pathways involved in promoting myelin synthesis. ENDECE Neural is developing NDC-1308, which appears to directly induce OPCs to differentiate into mature oligodendrocytes that restore the depleted myelin sheath in patients with MS. ENDECE Neural discovered and owns the intellectual property surrounding its compounds, and the company’s management team has an extensive track record of successfully taking products from the laboratory through FDA approval and commercial release.

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Multiple Sclerosis Appears to Originate in Different Part of Brain Than Long Believed

Rutgers professor’s advanced analysis could let therapy start earlier and lead MS research in new directions

The search for the cause of multiple sclerosis, a debilitating disease that affects up to a half million people in the United States, has confounded researchers and medical professionals for generations. But Steven Schutzer, a physician and scientist at Rutgers New Jersey Medical School, has now found an important clue why progress has been slow – it appears that most research on the origins of MS has focused on the wrong part of the brain. 
Look more to the gray matter, the new findings published in the journal PLOS ONE suggest, and less to the white. That change of approach could give physicians effective tools to treat MS far earlier than ever before.   
Until recently, most MS research has focused on the brain’s white matter, which contains the nerve fibers. And for good reason: Symptoms of the disease, which include muscle weakness and vision loss, occur when there is deterioration of a fatty substance called myelin, which coats nerves contained in the white matter and acts as insulation for them. When myelin in the brain is degraded, apparently by the body’s own immune system, and the nerve fiber is exposed, transmission of nerve impulses can be slowed or interrupted. So when patients’ symptoms flare up, the white matter is where the action in the brain appears to be.
brain and upper spine
Image: Shutterstock
Fluid drawn from the central nervous system contained proteins whose discovery may change the focus of multiple sclerosis research and lead to earlier diagnosis and treatment of the disease.
But Schutzer attacked the problem from a different direction. He is one of the first scientists to analyze patients’ cerebrospinal fluid (CSF) by taking full advantage of a combination of technologies called proteomics and high-resolution mass spectrometry. “Proteins present in the clear liquid that bathes the central nervous system can be a window to physical changes that accompany neurological disease,” says Schutzer, “and the latest mass spectrometry techniques allow us to see them as never before.” In this study, he used that novel approach to compare the cerebrospinal fluid of newly diagnosed MS patients with that of longer term patients, as well as fluid taken from people with no signs of neurological disease.
What Schutzer found startled one of his co-investigators, Patricia K. Coyle of Stony Brook University in New York, one of the leading MS clinicians and researchers in the country. The proteins in the CSF of the new MS patients suggested physiological disruptions not only in the white matter of the brain where the myelin damage eventually shows up. They also pointed to substantial disruptions in the gray matter, a different part of the brain that contains the axons and dendrites and synapses that transfer signals between nerves.   
Several scientists had in fact hypothesized that there might be gray matter involvement in early MS, but the technology needed to test their theories did not yet exist. Schutzer’s analysis, which Coyle calls “exquisitely sensitive,” provides the solid physical evidence for the very first time. It includes a finding that nine specific proteins associated with gray matter were far more abundant in patients who had just suffered their first attack than in longer term MS patients or in the healthy controls. “This evidence indicates gray matter may be the critical initial target in MS rather than white matter,” says Coyle. “We may have been looking in the wrong area.”
According to Coyle, that realization presents exciting possibilities. One, she says, is that patients who suffer attacks that appear related to MS could have their cerebrospinal fluid tested quickly. If proteins that point to early MS are found, helpful therapy could begin at once, before the disease can progress further. 
Coyle says Schutzer’s findings may also lead one day to more effective treatments for MS with far fewer side effects. Without specific knowledge of what causes multiple sclerosis, patients now need to take medications that can broadly weaken their immune systems. These drugs slow the body’s destruction of myelin in the brain, but also degrade the immune system’s ability to keep the body healthy in other ways. By suggesting an exciting new direction for MS research, Schutzer and his team may have set the stage for more targeted treatments that attack MS while preserving other important immune functions.     


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Biogen Idec, Elan facing suits over MS drug side effects

New lawsuit rekindles controversy over rare brain disease linked to multiple sclerosis therapy - Business - The Boston Globe

Despite living with multiple sclerosis since 1997, Kimberley A. Yout kept a busy schedule, working full time as a money manager for a Boston bank and modeling in her spare time.

That changed on Aug. 28 of last year when Yout, 45, was diagnosed with a rare brain infection that developed as a side effect of Tysabri, a drug she took for six years to keep her MS in check. Yout’s speech became slurred, her gait unsteady, and her future uncertain.

“I was a very successful businesswoman,” said Yout, who lives in Hanover. “Today, I can’t even balance my checkbook, I can’t use an ATM, I can’t see out of one eye. I had to move back in with my mother. I’ve lost my independence. I’ve lost everything.”

Now, she is suing the two companies that marketed Tysabri — Biogen Idec Inc. of Weston and the Irish drug maker Elan Pharmaceuticals Inc. — in Middlesex Superior Court in Woburn. Her complaint, filed Friday, alleges they failed to adequately warn patients of the risks some face from prolonged use of Tysabri.

The lawsuit is one of at least a half-dozen pending in Massachusetts and federal courts in three other states. In each case, plaintiffs are seeking more than $1 million in punitive damages from Biogen Idec and Elan on behalf of patients or their families. After taking Tysabri, the patients developed progressive multifocal leukoencephalopathy, known as PML, an infection of the brain’s white matter that can cause death or severe disability.

Many doctors consider Tysabri highly effective in slowing the progression of relapsing forms of MS, a neurodegenerative disease, in adults for whom other drugs have stopped working. That’s why many of them take it, despite the risks.
Biogen Idec has been working to move beyond nearly a decade of controversy over Tysabri. Last year, it altered the drug’s label to include new safety information and introduced blood tests to help doctors identify patients’ risk level for PML. But the new suit and those pending are again raising questions about the drug’s safety.

Tysabri was approved by the Food and Drug Administration in 2004. But Biogen Idec and Elan pulled it from the market in 2005 after several PML cases, two of which resulted in death. The companies reintroduced the drug in 2006, with the approval of regulators, along with a “risk management” program that trains physicians prescribing Tysabri and requires them to monitor patients monthly under strict guidelines.

The approval for Tysabri, despite its chance of causing brain infections, was not unique. Regulators sometimes allow potentially dangerous drugs on the market if the disease they seek to ameliorate is severe, and they determine the benefits outweigh the risks.

read more

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Monday, September 9, 2013

28 Devices That Make Life With MS Easier

Assistive Devices for MS

These “assistive” tools and products are designed to help you feel more steady on your feet -- from eating and cooking to using the bathroom and dressing yourself.

There is a variety of assistive devices that can help you manage the symptoms of  multiple sclerosis (MS). An assistive device is a tool or product that makes a certain function easier to perform. An occupational or physical therapist can prescribe these devices.
Below find a list of assistive devices and equipment that are available.

Mobility Aids for Multiple Sclerosis

Orthotics: Orthotics are lightweight inserts worn inside the shoes that can be used to increase stability and decrease fatigue. Orthotics can help with spasticity in the foot and can help brace the foot.
Leg braces: Weakness of the leg muscles may make it more difficult to maneuver on stairs, rise from a chair, or walk. An ankle-foot brace can stabilize the ankle when there is weakness in the foot muscles. This brace fits into an ordinary shoe and prevents the toes from dragging. If muscle weakness occurs in the neck, a neck brace may be recommended to make you more comfortable.
Canes: A cane may be the most useful tool when one leg is weaker than the other, or when you have mild problems with balance. Here are some guidelines for cane use:
  • The cane should be held on the stronger side of the body while the weight is shifted away from the weaker side.
  • A quad cane (or four-legged cane) provides more stability than a standard cane.
It is a good idea to have a session with a physical therapist to learn how to properly use your cane.
Walkers: Walkers may be more appropriate when there is significant leg weakness. They can also provide support for maintaining balance. Wheels or platforms may be added to the walker if necessary.
Wheelchairs or scooters: Wheelchairs or power scooters may provide more independence. These are usually recommended when a person experiences excessive fatigue, unsteadiness, or occasional falls. A scooter can add a great deal of independence for a person with limited mobility.

Aids for Activities of Daily Living

  • Tub bench
  • Hand-held shower head
  • Grab bars installed in shower/tub
  • Bedside commode
  • Grab bars near toilet
  • Toilet seat with armrests (a raised seat with armrests can be placed over a regular toilet)
  • Velcro, buttons, zippers, and hooks on clothing
  • Sock pull
  • Long-handled shoehorn
  • Buttonhook
  • A stool for sitting while dressing
  • Microwave oven
  • Wheeled utility cart
  • Electric can opener
  • Pot stabilizer
  • Specialized utensils, such as large-handled spoons and forks, or ''sporks,'' and rocker knives
  • Plate guard
  • Wrist supports
  • Special grips for pens and pencils
  • Wrist supports
  • Electric beds or mattresses
  • Reacher devices
  • Grab bars



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Dispelling the misconceptions about multiple sclerosis

Sept 7, 2013

By nancy heckler — Contributing columnist

With so many advances in medicine in the past 20 years, it's hard to believe that there were no FDA-approved medications available for multiple sclerosis before 1993.

Today, there are 10 drugs on the market that effectively manage the disease, with several more in development and nearing the approval stage.

MS is a chronic, sometimes debilitating condition in which an individual's own immune system attacks the myelin, the protective insulation around the nerves of the central nervous system.

Continue Reading


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Researchers find possible link between sleep and multiple sclerosis: Discoveries

CLEVELAND, Ohio-- Sleep may play a key role in the production and repair of myelin, the protective covering of nerve cells that is attacked and damaged in people with multiple sclerosis, according to early research in mice carried out at the University of Wisconsin.

The research found that the rate of production of a type of brain cell called oligodendrocyte precursor cells (OPCs) doubled in sleep relative to waking. OPCs are a type of cell that give rise to myelin in both healthy and injured adult brains.

“OPCs are among the few brain cells that in an adult brain keep proliferating and dividing and producing more cells,” said Dr. Chiara Cirelli, a professor in the department of psychiatry at the University of Wisconsin and senior author on the paper, which was published online Sept. 4 in The Journal of Neuroscience. “Most all neurons in the adult brain don’t do that—that’s why people are studying them now quite extensively.”

Cirelli began studying the functions of sleep about 15 years ago, by looking at all the genes that change in an animal’s brain during sleep versus waking. In a 2004 study in the journal Neuron, her research group found that up to five percent of genes expressed in the cortex or "gray matter" of the brain change solely due to whether an animal is asleep or awake.

In the current study, they looked specifically at OPCs, a type of glial cell. Glial cellsare all the brain cells that are not neurons, and used to be thought of as simply the "glue" of the brain, whose only function was to support the neurons. Now, the glia, which have been discovered to help maintain the brain’s internal equilibrium and produce myelin (among other functions), are the subject of intense scientific focus.

In Cirelli’s current research, sleep-triggered genes produced OPCs, while sleep deprivation led to a suppression of these genes and more activity in genes that have been implicated in cell death and stress responses.

The findings suggest that chronic sleep loss could aggravate symptoms of diseases like MS which involve damage to myelin, Cirelli said, but there is a lot more work to be done before any firm conclusions can be drawn in people.

“Disturbed sleep may aggravate perhaps the symptoms of the disease, in a vicious cycle,” she said. “It would be nice to try to block the vicious cycle and improve the quality of sleep in these patients.”

footnote: Stuart - can certainly agree with the above article


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Preparing for Emergencies

Hurricanes, floods, fires, blizzards, earthquakes, ice storms, mud slides, power outages. They can strike fear in anyone. For those of us living with MS, they can seem overwhelming. But don’t panic. People with disabilities are often better at coping with emergencies than others. Living with MS every day teaches us how to handle the unexpected. With planning, we and our families and caregivers can feel confident.

Research resources in your area

Most communities have an emergency management agency or office. Look in the government section of your phone book—usually the blue pages—and contact it. This organization coordinates the traditional “first responders,” including fire and police departments, the American Red Cross, and others. Explain your special needs and find out what, if any, public preparations are in place (such as hurricane or tornado shelters).

Make escape plans

Everyone’s situation is unique, so every plan is unique. What will you need if:
  • An emergency is confined to one location (a house fire).
  • Affects the whole region (a blizzard).
  • Affects you uniquely because of MS (a heat wave or drought with water restrictions).
You are the key to a good plan because you know best what your abilities are when you are at your worst. And remember, the first time you try out your escape plans shouldn’t be an occasion when you need them.


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Affording Stair Lifts, Ramps, and Wheelchairs

Be a smart consumer when it comes to buying wheelchairs, ramps, and stair lifts. That means paying the lowest possible price for the best possible equipment. Doctors don’t necessarily know the best and latest equipment, so here are some tips:
  • Ask for a referral to an occupational or physical therapist (OT or PT) and for the names of reputable local vendors, preferably with CRTS staff (certified rehab technology supplier).
  • Shop at a medical equipment provider, sometimes called a rehabilitation technology or assistive technology supplier.
  • Ask if the vendor participates in Medicare or Medicaid if you are a beneficiary.
  • Be sure the vendor is accredited by RESNA, the Rehabilitation Engineering & Assistive Technology Society of North America.

Paying for it

Medicare, Medicaid and most private insurance plans cover prescribed wheelchairs, ramps and lifts to some extent. Be prepared to face rejection the first time you submit a claim. But keep trying; insurers respond to persistence. Here’s how to bolster your case:
  • Check insurance coverage and restrictions, including required paperwork, such as a doctor’s prescription and pre-approval.
  • Organize the information required for reimbursement, such as the nature and onset of your disability, employment history, family gross income and monthly expenses.
  • Prepare a justification statement if required. Tell your health-care professional to ask the Society for a CD titled Appeal Letters for Insurance. This disc contains model letters that meet standard requirements for insurance claims.
  • Check Medicare coverage. You can maximize your benefits by using a medical supplier (vendor) who agrees to accept the Medicare-approved amount as payment in full. You generally pay your 20% co-pay and any remaining Medicare Part B deductible. Non-participating suppliers do not have to accept assignment. Their charges may be higher and you will also have to wait for Medicare to reimburse you.
  • For Medicaid, check coverage with your state Medicaid office. Find the number in the State Government section of your phone directory, probably under Health Services or Health and Human Services (names vary by state). Or call your Society chapter.
  • Check your vendor’s return policy and your insurance claims appeal process. Keep meticulous records. Save all letters and notes of phone conversations. If it comes to it, follow the appeals process, and complete all the steps on time.

Affording ramps

To help defray costs, ask if a local service organization, school carpentry class or carpenter’s union would build your ramp as a service project. Staff at the Society chapter nearest you may know of similar projects. Call your chapter first!

The Minnesota Ramp Project offers a modular design for ramps or low steps that can be built either on or off your site. The comprehensive how-to plan comes with tips on using volunteer builders or finding financing. It can be downloaded free.

Buying used equipment

Secondhand equipment can cost half the original price. It can also be the best way to acquire backups or special-use wheels. Secondhand may even be a smart choice for a primary chair—if you don’t meet your insurance plan’s criteria but need the help that wheels provide.
  • Start your search through a good medical equipment vendor.
  • See if your chapter newsletter has any classified ads for used items.
  • Check the classified ads of publications for people with disabilities.
  • Look for online offers at craigslist or eBay.
  • Get the word out—ask people if they know of any used equipment for sale.

Buyer beware

Give used equipment a thorough check-up. If you buy used equipment from a private party, ask a medical equipment vendor check it out—just as you’d take a used car you’re considering to a reliable mechanic. Ask the vendor if it is willing to repair the equipment should you need that.

Check with a physical or occupational therapist who can measure used equipment to ensure it fits you. An experienced therapist can also help you pick the less problematic of two compromise choices.

Other sources of funding

  • If mobility will help you find or keep paid employment, you may be eligible for a grant from your state’s vocational rehabilitation agency.
  • Call your Society chapter and ask for referrals to foundations or agencies, such as Easter Seals.
  • You might also consider a loan tailored for people with disabilities. The Digital Federal Credit Union offers special Mobility Vehicle and Access loans to members of the American Association for People with Disabilities.

Tax credit help

You should be able to deduct out-of-pocket costs for medical necessities from your federal taxes. To support these deductions in an IRS audit, get a letter from your prescribing doctor, and keep a copy of your prescription in your file.


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Assistance Animals

Service dogs work as guide, therapy, hearing, and assistance dogs for people with disabilities. Service dogs come in all breeds and sizes. Some are mixed breeds or are rescued from shelters. Service dogs can be trained to perform an impressive range of tasks, including: 
  • guiding
  • alerting to sounds
  • opening and closing doors
  • retrieval
  • pulling wheelchairs
  • providing balance support
  • turning lights on and off
  • responding to changes in the physiological, mental, or emotional state of their human partners.

Time, care, and love

The number of people with MS who have service animals is growing every year. Still, service animals are not for everyone with a disability. They require time, money, and care that you must be able and willing to provide.
Every kind of service dog has basic needs that must be met:
  • food and water
  • daily exercise
  • veterinary care
  • care for bodily functions (i.e., walking or grooming)
  • affection and attention
  • ongoing training
In addition, dogs need socialization with other dogs. Here are some questions you should ask yourself.
  • Do you have the funds, time, and support to meet your service dog’s needs?
  • Are you able to exercise a dog and clean up after him or her? Do you have a reliable person willing to do this when you can’t—come rain, snow, sleet, hail, summer heat, or an MS flare?
  • Do you have or can you raise funds to pay for regular veterinary care, as well as food, accessories, and training aids? If funds are tight, have you researched potential financial resources? (Help may be available.)
  • Will you be consistent in working with your service dog and use the training techniques you will learn? Can you be patient if a training routine is not going well, and figure out ways to turn it around?
  • Are you willing to make a ten-year, or more, committment to a dog?

What do you want?

You should carefully consider your wants and needs. Learn about the differences between a service dog and a therapy or a companion dog (there are many differences, including legal). Also think about what kind of support and tasks you would like your service dog to provide.

Where to start

Take time to research the process of acquiring a service dog -- the responsibilities, requirements and benefits. Be realistic about your expectations and limitations.
Assistance Dogs International, a coalition of not-for-profit organizations that train and place assistance dogs, is a good place to start.
Make sure that you understand and agree with the policies and procedures of any agency, organization, or professional trainer you decide to work with. Here are some questions to ask:
  • What is the application process?
  • Is there an application fee?
  • Will I be the animal’s legal owner?
  • Do you follow up after placement? How and at what cost?
  • What will the training process be? How long will it take? How much am I involved in the process?
  • Do you offer custom training for my specific needs?
  • Have you worked with people with MS before?
  • Do you provide references from people who are using your assistance dogs? 
In turn, you will be asked many questions about your needs, preferences, and living conditions. Organizations may request medical or financial records—make sure you ask how they will be used and who will be reviewing them. You might be required to provide a prescription.
There are no uniform standards or credentialing processes for service animal trainers, so it’s important to do your homework before you sign any papers.


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