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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance thinking skills and daily functioning for people with multiple sclerosis (MS) who struggle with processing information, memory, and planning tasks. Participants will join one of two groups: one receiving Goal Management Training (a specialized program to boost cognitive skills) and the other continuing with regular care. It suits those diagnosed with MS who notice difficulties in mental tasks and can attend in-person sessions. The trial will measure improvements in how quickly and effectively participants process information, aiming to boost overall life quality.

As an unphased trial, this study offers a unique opportunity to contribute to understanding cognitive interventions for MS, potentially improving daily life for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used steroids in the past 3 months.

What prior data suggests that this cognitive rehabilitation program is safe for individuals with multiple sclerosis?

Research has shown that Goal Management Training (GMT) is generally safe for people with multiple sclerosis (MS). Studies have not found an increased risk of relapses or serious side effects with GMT. More than 80 studies support GMT's effectiveness in improving skills like planning and organizing in various conditions, including MS. This suggests that GMT is well-tolerated and may offer cognitive benefits without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Goal Management Training (GMT) for multiple sclerosis because it's a fresh approach that targets cognitive rehabilitation directly. Unlike existing medications that primarily address physical symptoms or modify disease progression, GMT focuses on enhancing cognitive functions like memory and attention, which are often affected by multiple sclerosis. The training involves structured, interactive sessions that help patients improve goal-oriented behavior, offering a potentially impactful way to boost quality of life through cognitive empowerment.

What evidence suggests that Goal Management Training is effective for cognitive rehabilitation in multiple sclerosis?

Research has shown that Goal Management Training (GMT), which participants in this trial may receive, can improve thinking skills in people with multiple sclerosis (MS). One study found that GMT led to moderate improvements in skills like planning and organizing, with benefits often lasting over time. GMT shows promise in helping people manage daily thinking challenges. While evidence for other methods to enhance thinking skills in MS is limited, GMT stands out as a helpful option. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

I do not use illicit drugs except for cannabis.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5455978/

Functional training is a senseless strategy in MS cognitive ... MS patients have demonstrated good adherence to computerized cognitive training programs, even when self-administered at home. ... The safety and acceptability of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5304985/

Efficacy of a short cognitive training program in patients with ... Systematic reviews on cognitive rehabilitation in MS have not found evidence to support its effectiveness.

3. tandfonline.com tandfonline.com/doi/full/10.1080/09602011.2018.1438294

Effectiveness of goal management training® in improving ... The analysis suggests that GMT is an effective intervention, leading to moderate improvements in executive functions that are usually maintained at follow-up.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213158225000452

A randomised clinical trial in patients with multiple sclerosis In MS, GNPT temporarily improves verbal memory and increases network connectivity, reinforcing the CR as a valuable tool for enhancing cognitive skills and ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1130231/full

Cognitive rehabilitation in multiple sclerosis: Three digital ... Cognitive rehabilitation (CR) aims at reducing CI and improving PwMS' awareness of cognitive difficulties faced in their daily living.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637110/

Safety of exercise training in multiple sclerosis - PubMed Central In studies that reported safety outcomes, there was no higher risk of relapse, AE, adverse effects or SAE for exercise training than the comparator.

7. gmt.learnworlds.com gmt.learnworlds.com/research-overview

Research There are over 80 publications concerning the effectiveness of GMT for improving executive functioning in aging, traumatic brain injury, spina bifida, multiple ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034825003657

Exercise Training in Multiple Sclerosis: Preparing for ... Exercise training is safe (Learmonth et al., 2023) and beneficial (Motl, Sandroff, et al., 2017) in MS. Benefits include improving balance, physical and ...

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0263108

A feasibility pilot trial | PLOS One - Research journals The aim of this study was to test ease of implementation, differential safety and preliminary efficacy of two top-down (strategy-learning) home-based, ...