ALS Canada’s clinical management grants

Updated October 20, 2017

Staying active and independent for as long as possible is important for people living with ALS as the disease progresses. There are many ways in which to manage symptoms or receive care, but there often isn’t enough research performed to determine which approaches make the greatest difference.

To help address these knowledge gaps and pave the way for better care, ALS Canada funds Clinical Management Grants thanks to donations from the Ice Bucket Challenge. So far, two clinical management grants have been awarded: one that focuses on helping people living with ALS to drive safely for longer, and another that is researching the use of cannabis (marijuana) to help manage pain and discomfort.

Driving Assessment: Helping People with ALS to Drive Safely, Longer

Associated with independence, driving is a complex activity that requires physical, emotional and mental focus. Unfortunately, many of these abilities decline as ALS progresses. Unlike other diseases like stroke or Parkinson’s, there are few published resources to measure when a person’s ALS has progressed to the point that driving becomes unsafe. As a result, ALS clinical care teams regularly face decisions about when to discuss driving with patients and families, whether someone living with ALS can drive safely, or if a referral for an on-road test is needed.

A retrospective review conducted by members of the ALS Clinic at the Montreal Neurological Institute & Hospital (MNI/H) found that many people with ALS were not making changes to their vehicles that had the potential to enable them to prolong driving: for example, adapted foot controls can help with pedal access, a ball installed on the steering wheel can help with steering; and a BiPAP machine secured in the vehicle can help with breathing.

To help empower people living with ALS, the clinic at the MNI/H, led by Dr. Angela Genge, is implementing a multidisciplinary, systematic approach to assess driving safety. “This initiative focuses on how the whole care team can help people with ALS drive safely for a longer length of time,” said Kendra Berry, the clinic’s occupational therapist, in an interview with ALS Canada.

Berry, who recognized the gap in care several years ago, is collaborating with the entire MNI/H multidisciplinary ALS clinic team on this initiative. After reviewing existing broad guidelines for other conditions, the clinical team is trying to establish a standardized driving assessment to be used in their clinical setting. The complete assessment incorporates the ALSFRS-R, a cognitive behavioural screen, and questionnaires for people with ALS and caregivers. Berry has also accumulated a battery of tasks to simulate driving actions that she is incorporating into regular clinic assessments.

With all this input, the team will develop checkpoints that the whole care team can use to help people with ALS decide when they may benefit from an adaptation, need to be referred for a road test or transition to giving up driving.

“We start the conversation at the first or second visit, rather than the usual timing of a year or two after diagnosis,” said Berry. Earlier discussion and driving assessment mean that people with ALS are empowered to access driving adaptations earlier.

The project is set to launch the week of August 28, 2017, and the team will follow about 200 study participants for two years. When the project is complete, they plan to share their learning with ALS clinicians across Canada and the SAAQ in Quebec, the provincial licensing authority for drivers’ licenses, which could help pave the way for other provincial and national groups to adopt them in the future.

Studying the use of cannabis extracts to manage ALS pain and discomfort

In surveys, people with ALS have reported that cannabis (marijuana) helps to alleviate weakness, speech difficulties, excessive saliva production, difficulty swallowing, breathing issues, pain and stiff muscles, and can improve sleep, appetite and mood.

Yet while cannabis has been used for symptom management by anywhere from 15 to 40 per cent of people with HIV/AIDS, epilepsy, chronic pain, multiple sclerosis and ALS, often the doctors providing care aren’t aware that their patients are using it.

In 2012, ALSUntangled conducted a review of cannabis studies and potential in ALS.

Studies of the effect of cannabis on ALS to date have used animal models or small numbers of people with single doses of only one ingredient – whereas cannabis contains over 480 compounds. The two most well-known active ingredients are tetrahydrocannabinol (THC), the psychoactive component that has been linked to analgetic action, appetite stimulation, decreased muscle stiffness and improved sleep; and cannabidiol (CBD), which has been studied for anti-inflammatory, anti-anxiety and anti-nausea benefits.

“THC, CBD and other ingredients in cannabis affect many different systems in the body,” said Dr. Mark Ware during the ALS Canada Virtual Research Forum on August 9, 2017. “For example, THC works by binding to a specific receptor found in the brain, spinal cord, the gastrointestinal tract and other body tissues. By affecting these receptors, cannabis has an impact on the ways our nerves talk to one another.”

Dr. Ware has been conducting cannabis research for medical purposes for almost 18 years, mostly in the area of pain management. He is executive director of the Canadian Consortium for the Investigation of Cannabinoids, director of Clinical Research at McGill University Health Centre’s Alan Edwards Pain Management Unit, and an associate professor in the Departments of Family Medicine and Anesthesia at McGill University in Montreal, Quebec.

With a clinical management grant through the ALS Canada Research Program, Dr. Ware is leading a team of Canadian researchers who will conduct a pilot study of the use of cannabis in 32 people with ALS starting later this fall. The other co-investigators include Dr. Angela Genge, director of the ALS Clinic and Clinical Research Unit at the MNI in Montreal, Quebec, and Dr. Colleen O’Connell, a neurologist specializing in physical medicine and rehabilitation who leads the ALS Clinic at the Stan Cassidy Centre for Rehabilitation in Fredericton, New Brunswick and is an assistant professor at Dalhousie University in Halifax, Nova Scotia.

The researchers are working with Green Sky Labs, a Canadian company licensed by Health Canada to grow marijuana for medicinal purposes, to obtain oral capsule products with different ratios of THC and CBD formulated in a medical-grade oil. Study participants with ALS will be part of a crossover study over an eight week period, with five days on one dose, followed by a nine day washout period, then another five days on a different dose, until all four ratios have been administered. Researchers will collect information about ALS symptoms, pain, mood, sleep, appetite, cardiovascular and respiratory effects, and any adverse effects.

Health Canada is currently reviewing Green Sky Labs’ application for product approval. The researchers expect to begin the study by the early 2018. Results from this pilot study will inform future research studies that could seek to explore whether cannabis can slow disease progression.

Clinical Management Grants are one category of high-quality research funded through the ALS Canada Research Program. Read more about the ALS Canada Research Program and consider donating today.

ALS Canada Virtual Research Forum

Update: Dr. Ware was one of more than 20 speakers who participated in the ALS Canada Virtual Research Forum in August. You can listen to his full presentation online here.

Posted in: Research