Cognitive Rehabilitation for Multiple Sclerosis

Overseen By Cecilia Meza, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Steroids, Stimulants, Barbiturates, others

Disqualifiers: Other CNS diseases, Psychotic symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 5 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Cognitive rehabilitation is designed to enhance a person's capacity to process and interpret information and improve their ability to function in all aspects daily, family and community life. Given the clear and consistent documentation of cognitive deficits in persons with MS, the most notable deficit being information processing speed, learning and memory and executive function, there is an obvious need for effective cognitive rehabilitation. The proposed study will be a randomized controlled single-blinded trial with treatment and wait-list control group. The treatment group will be administered the Goal Management Training (GMT) program; the wait-list control group will be given usual care by their neurologist. Intervention details: The treatment group will receive in-person computerized cognitive rehabilitation (using the GMT program) (virtual training is optional) for 5 weeks (40-min sessions, twice per week), session will be tailored according to patient cognitive concerns at index assessment, and level of ability. The wait list control group, will not receive treatment Our primary outcome is information processing speed, secondary aims include learning and memory, and executive function. The minimal assessment of cognitive function in MS (MACFIMS) will be utilized to assess cognitive function. Additionally, tertiary aims include the following patient reported outcomes (PROs) will be collected: the hospital anxiety and depression scale (HADS), the modified fatigue impact scale (MFIS), the multiple sclerosis impact scale (MSIS-29), and the European quality of life (EQ-5D-5L) scale, to capture level of depression and anxiety, fatigue, impact of MS and quality of life. Cognitive performance of all patients in both groups will be assessed at baseline, immediate post-5-week assessment, and at post 6-month follow-up assessment. We hypothesized that, compared to persons in the wait-list group, the participants receiving the GMT intervention will demonstrate significant improvements across all cognitive measures. The wait-list control group will be given the option to receive the GMT intervention after the 6 months follow-up is complete. The individuals in the treatment group, wishing to continue with the GMT program, will be given a referral by Dr. Feinstein to a GMT certified therapist.

Eligibility Criteria

This trial is for individuals with Multiple Sclerosis who experience cognitive challenges, particularly in processing information, learning and memory, or executive function. Participants must be willing to undergo cognitive rehabilitation training.

Inclusion Criteria

Corrected near vision of 20/70 or better (to see test material)

I have been diagnosed with a form of multiple sclerosis.

A performance below 1.5 or 2 standard deviations (SD) compared to the normative mean in at least 20-30% of the test parameters

Exclusion Criteria

I cannot travel to the Centre on my own or need an ambulance for transportation.

I have not taken steroids in the last 3 months.

Psychotic symptoms, bipolar disorder, schizophrenia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment group receive in-person computerized cognitive rehabilitation using the GMT program for 5 weeks, with optional virtual training

5 weeks

10 visits (in-person), optional virtual sessions

Follow-up

Participants are monitored for cognitive performance and other outcomes at 6 months post-treatment

6 months

1 visit (in-person)

Open-label extension (optional)

Wait-list control group participants have the option to receive the GMT intervention after the 6-month follow-up

Treatment Details

Interventions

• Goal Management Training

Trial Overview The study tests Goal Management Training (GMT) as a form of cognitive rehabilitation for MS patients. It's a randomized controlled trial where the treatment group receives GMT sessions over 5 weeks and their progress is compared to a wait-list control group receiving usual care.

Participant Groups

Group I: cognitive rehabilitation group Experimental Treatment 1 Intervention

will be treated by GMT for 5 weeks (two hour sessions per week, one day of rest in between).

Group II: wait-list control group Active Control 1 Intervention

will be given a list cognitive compensatory strategies that they can do on their own to improve their memory.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+