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

NCT ID: NCT06608797

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Training

Computer based cognitive training delivered remotely via Zoom Health

Group Type: EXPERIMENTAL

Learning and memory training

Intervention Type: 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

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).

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Silvana Costa

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Silvana L Costa Research Scientist, PhD

Role: CONTACT

scosta@kesslerfoundation.org

973 324 8458

Facility Contacts

Silvana M Lopes Costa, PhD

Role: primary

scosta@kesslerfoundation.org

9733248458

Emily Fernandez

Role: backup

efernandez@kesslerfoundation.org

973-323-3759

Other Identifiers

E-1259-24

Identifier Type: -

Identifier Source: org_study_id