Computer-based Cognitive Training for Multiple Sclerosis

Overseen By Silvana L Costa Research Scientist, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Recent exacerbation, Neurological history, Major depressive disorder, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: 10

Duration: 5 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Cognitive impairments are common in multiple sclerosis (MS) diagnosed both at the onset and throughout the disease course. Poor cognitive abilities have been associated with poor outcomes such as higher levels of unemployment, poor quality of life, driving difficulties among others. Learning and memory are a common cognitive deficit. This computer-based cognitive training is a 10-session treatment proven to be effective in ameliorating learning and memory in individuals with MS across 3 realms of functioning: objective cognitive performance, daily life activities and neuroimaging. Despite this strong efficacy, as well as the recent clinical application of this computer-based cognitive training across the world, recent in-person studies have highlighted that transportation to the clinic to complete treatment sessions is a significant obstacle to clinical use of this effective treatment. To address this limitation, the proposed pilot study will test the efficacy of the computer-based cognitive training administered remotely via zoom health in persons with multiple sclerosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Computer-based Cognitive Training for Multiple Sclerosis?

Research shows that computer-based cognitive training can improve cognitive performance in people with multiple sclerosis, particularly in areas like memory, attention, and processing speed. Studies indicate that this type of training can lead to moderate improvements in cognitive functioning, making it a promising tool for managing cognitive deficits associated with the condition. ^{1 2 3 4 5}

Is computer-based cognitive training safe for humans?

Computer-based cognitive training has strong evidence for safety in several populations, including those with multiple sclerosis, and is generally well-tolerated. ^{2 4 6 7 8}

How does computer-based cognitive training differ from other treatments for multiple sclerosis?

Computer-based cognitive training is unique because it specifically targets cognitive deficits like processing speed and working memory through interactive exercises on a computer, unlike traditional treatments that may focus more on physical symptoms. This approach has shown moderate improvements in cognitive functions, making it a promising supplement to standard care for multiple sclerosis. ^{2 4 5 8 9}

Eligibility Criteria

This trial is for individuals with multiple sclerosis who speak English as their primary language. It aims to help those facing cognitive challenges, particularly in learning and memory, which can affect daily life and employment.

Inclusion Criteria

English is my primary language.

I have been diagnosed with multiple sclerosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive computer-based cognitive training remotely via Zoom Health, consisting of 10 sessions

5 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Computer-based Cognitive Training

Trial Overview The study tests a computer-based cognitive training program delivered remotely via Zoom Health over 10 sessions. The effectiveness of this treatment will be measured by improvements in cognitive performance, daily activities, and neuroimaging results.

Participant Groups

Group I: Training Experimental Treatment 1 Intervention

Computer based cognitive training delivered remotely via Zoom Health

Group II: sham comparator Placebo Group 1 Intervention

The sham comparator group will receive sham memory exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 placebo control sessions).

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Findings from Research

In a study involving 62 patients with multiple sclerosis, a computer-assisted neuropsychological training program significantly improved cognitive functions such as verbal memory, working memory, and phonetic fluency over 3 months compared to a control group.

The training also led to a notable reduction in anxiety symptoms and an improvement in quality of life for the patients, highlighting its potential benefits beyond cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a short cognitive training program in patients with multiple sclerosis. Pérez-Martín, MY., González-Platas, M., Eguía-Del Río, P., et al.[2020]

In a pilot study involving multiple sclerosis patients, six weeks of computerized cognitive training led to significant improvements in processing speed and attention for those in the active training group.

The results suggest that cognitive training may offer moderate benefits in cognitive functioning for multiple sclerosis patients, particularly in processing speed and working memory, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study. Hancock, LM., Bruce, JM., Bruce, AS., et al.[2022]

A meta-analysis of 9 studies showed that computer-based cognitive training significantly improves memory performance in patients with multiple sclerosis (MS), with a notable effect size (SMD of 0.22).

Specifically, the training had a strong impact on delayed memory as measured by the Selective Reminding Test, indicating that cognitive rehabilitation can be an effective intervention for addressing cognitive decline in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of computer-based cognitive training in neuropsychological performance of patients with multiple sclerosis: A systematic review and meta-analysis. Dardiotis, E., Nousia, A., Siokas, V., et al.[2018]

In a study of 40 MS patients with mild to moderate cognitive impairment, both traditional cognitive rehabilitation (TCR) and computerized cognitive rehabilitation (CCR) were well-tolerated and improved cognitive function.

The computerized rehabilitation using the ERICA software significantly enhanced memory, attention, and processing speed more effectively than traditional methods, suggesting it could be a valuable tool in cognitive rehabilitation for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do people with multiple sclerosis benefit from PC-based neurorehabilitation? A pilot study. De Luca, R., Russo, M., Gasparini, S., et al.[2022]

In a pilot study involving 16 patients with relapsing-remitting multiple sclerosis (MS) and 9 age-matched controls, training with three-dimensional multiple-object tracking (3D-MOT) resulted in significant improvements in driving readiness for the MS group.

Despite initially lower scores in 3D-MOT, patients with MS showed similar improvements to controls, suggesting that 3D-MOT training is an effective and accessible tool for cognitive rehabilitation in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Three-Dimensional Multiple-Object Tracking in Patients with Multiple Sclerosis: A Pilot Trial. Harenberg, S., St Onge, J., Robinson, J., et al.[2023]

In a study of 58 patients with mild to moderate cognitive impairment due to multiple sclerosis, those who underwent 10 weeks of computer-assisted cognitive training showed significant improvements in memory, attention, and executive functions compared to those receiving standard care.

The cognitive gains, particularly in attention, were not only significant but also sustained for at least 6 months, indicating the long-term benefits of this targeted cognitive training intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Computer-Assisted Cognitive Rehabilitation Intervention in Relapsing-Remitting Multiple Sclerosis Patients: A Multicenter Randomized Controlled Trial. Messinis, L., Nasios, G., Kosmidis, MH., et al.[2019]

A home-based cognitive training program significantly improved verbal learning and working memory in 42 relapsing-remitting MS patients over a 6-week period, despite no changes in neurological status or quality of life.

The improvement in long-delay verbal memory performance was independent of brain atrophy, suggesting that cognitive training can be effective even in patients with early brain changes associated with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training in MS: effects and relation to brain atrophy. Hildebrandt, H., Lanz, M., Hahn, HK., et al.[2022]

Computerized cognitive training (CCT) has been shown to have a moderate positive effect on cognitive function in adults with multiple sclerosis (MS), based on a review of 20 randomized controlled trials involving 982 participants, primarily with relapsing-remitting MS.

While CCT improved key cognitive areas such as attention, executive functions, and memory, its effects diminished without ongoing training, and further research is needed to explore its impact on psychosocial functioning and daily life, especially in progressive MS subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training in Multiple Sclerosis: A Systematic Review and Meta-analysis. Lampit, A., Heine, J., Finke, C., et al.[2023]

In a study involving 45 patients with multiple sclerosis, both high intensity and distributed schedules of computer-based working memory training (BrainStim) significantly improved fatigue symptoms, working memory, and mental speed.

The results suggest that BrainStim can be effectively tailored to fit the personal schedules of MS patients, as both training methods yielded similar benefits, although no improvements were noted in short-term memory, quality of life, or depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working memory training in patients with multiple sclerosis - comparison of two different training schedules. Vogt, A., Kappos, L., Calabrese, P., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of a short cognitive training program in patients with multiple sclerosis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Processing speed and working memory training in multiple sclerosis: a double-blind randomized controlled pilot study. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of computer-based cognitive training in neuropsychological performance of patients with multiple sclerosis: A systematic review and meta-analysis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Do people with multiple sclerosis benefit from PC-based neurorehabilitation? A pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Three-Dimensional Multiple-Object Tracking in Patients with Multiple Sclerosis: A Pilot Trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of a Computer-Assisted Cognitive Rehabilitation Intervention in Relapsing-Remitting Multiple Sclerosis Patients: A Multicenter Randomized Controlled Trial. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive training in MS: effects and relation to brain atrophy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training in Multiple Sclerosis: A Systematic Review and Meta-analysis. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Working memory training in patients with multiple sclerosis - comparison of two different training schedules. [2022]