Improving cognition in people with Progressive Multiple Sclerosis: A Multi-Arm, Randomized, Blinded, Sham-Controlled Trial of Cognitive Rehabilitation and Aerobic Exercise

Investigators:

  • Dr. Anthony Feinstein, Sunnybrook Research Institute, Toronto, Canada
  • Dr. Jeremy Chataway, University College London, London, UK
  • Dr. Nancy Chiaravalloti, Kessler Foundation, East Hanover, USA
  • Dr. Gary Cutter, University of Alabama at Birmingham, Birmingham, USA
  • Dr. Ulrik Dalgas, Aarhus University, Aarhus, Denmark
  • Dr. John Deluca, Kessler Foundation, East Hanover, USA
  • Dr. Mara Rocca, Ospedale San Raffaele, Milan Italy

Term: June 1, 2018-May 31, 2022

Funding: $5,000,000.00

Keywords: cognition, exercise, quality of life, imaging

Project Summary:

  • Cognition 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 harmful effects on employment, relationships and activities of daily living.
  • There is an essential need to develop rehabilitation strategies that help people with MS manage their symptoms such as cognition.
  • The research team will:
    • Test if cognitive rehabilitation, or exercise, or a combined approach of cognitive rehabilitation and exercise will improve cognitive function.

Project Description:

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, and his international team of investigators are testing if cognitive rehabilitation, or exercise, or a combined approach of cognitive rehabilitation and exercise will improve cognitive function. They hypothesizes that a combined approach of these two therapies will be more beneficial than either one alone.

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 lesion changes, brain atrophy, and regions activated when the cognitive task is performed.

Potential Impact: 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 in people diagnosed with progressive MS.

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