Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Learning and memory training, Sham Comparator.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 19 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Learning and memory training
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). - Behavioral Sham Comparator
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 outcome measures
- 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 outcome measures (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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Kessler Foundation — East Hanover
Identifiers
NCT: NCT06608797 · E-1259-24