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NCT Number: NCT06608797

Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English as primary language
  • Diagnosis of multiple sclerosis

Exclusion criteria

  • Most recent exacerbation within one month
  • Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
  • Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
  • Poor Visual Acuity (corrected vision in worse eye < 20/60), diplopia, or nystagmus
  • Inability to understand directions and following one, two, and three step commands
  • Intact New Learning and Memory: Only individuals that show impaired performance on a memory test will be included in the study

Treatment and study plan

Learning and Memory Training

Behavioral

The experimental group will receive memory retraining exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 training sessions).

Sham Comparator

Behavioral

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).

Primary outcomes

  1. California Learning Verbal Test III

    Time frame: Primary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)

Secondary outcomes

  1. Ecological Memory Simulations

    Time frame: Secondary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)

Study contacts

Contact information is provided by the study sponsor or research team.

Silvana L Costa Research Scientist, PhD

CONTACT

[email protected]

973 324 8458

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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