Summary
The Multiple Sclerosis Society of Canada announced a $5 million, multicenter, international clinical trial to investigate if cognitive rehabilitation and aerobic exercise can improve cognition in people with progressive MS. The study has the potential to provide a treatment option for people living with progressive MS who are affected by cognitive difficulties.
Details
There are no effective disease-modifying therapies for people with secondary progressive MS who no longer experience relapses and only one therapy that is conditionally approved in Canada for early primary progressive MS. It is essential to develop rehabilitation strategies that help people with MS manage their symptoms. Cognitive dysfunction is considered an “invisible” symptom that can affect up to 70% of people with progressive MS and has been identified as an area of prime concern by people with MS given the significant impact it can have on employment, relationships, and activities of daily living.
To identify a potential treatment for cognitive difficulties experienced by people living with progressive MS, Dr. Anthony Feinstein, a neuropsychiatrist from the University of Toronto and Sunnybrook Health Sciences Centre, and his team of international MS rehabilitation specialists are testing if cognitive rehabilitation, or exercise, or a combined approach of cognitive rehabilitation and exercise will improve cognitive function. The research team hypothesizes that a combined approach of these two therapies will be more beneficial than either one alone.
The team of investigators for the study includes: Dr. John DeLuca and Nancy Chiaravalloti (Kessler Foundation, USA); Dr. Jiwon Oh (University of Toronto), Dr. Ulric Dalgas (Aarhus University, Denmark); Dr. Mara Rocca, Dr. Massimo Filippi (Ospedale San Raffele, Italy); Dr. Gary Cutter, Dr. Rob Motl, Dr. Brian Sandroff (University of Alabama at Birmingham, USA), Dr. Giampaolo Brichetto, Dr. Matilde Inglese (University of Genoa), Dr. Peter Feys (University of Hasselt, Belgium), Dr. Jenny Freeman (University of Portsmouth, England),Dr. Maria Pia amato (University of Florence, Italy) and Dr. Jeremy Chataway (University College London, England)).
The research team will enroll 360 people with progressive MS from 11 centres across six countries. Participants will be given treatment over the course of 12 weeks. Brain imaging using magnetic resonance imaging (MRI) will be conducted in a subgroup of 120 participants to see whether cognitive improvement is also linked to changes in lesion and brain atrophy, and improved regional brain activation during performance of a cognitive task. This clinical study is the first of its kind to use a large sample that incorporates many countries and has the potential to define how best to treat cognitive dysfunction.
Cognitive difficulties cast a long shadow and can negatively impact employment, relationships, and activities of daily living. Current treatment options to manage cognitive dysfunction are lacking. No study has yet to examine the combination of cognitive rehabilitation and exercise in MS. The proposed study is the first with a large enough number of participants to effectively demonstrate the potential benefits of these two interventions. Moreover, it has the potential to show that these interventions can be applied across treatment centres, countries and language groups. If the study findings conclude that the synergistic approach of cognitive rehabilitation and exercise is more beneficial than either intervention alone, the study will provide a viable treatment option for people with progressive MS who are affected by cognitive difficulties.
The MS Society will provide further information on Dr. Feinstein and his research team when updates become available. For more information, please check out the FAQ.