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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Learning and memory training; Behavioral: Sham Comparator

• Registration Number: NCT06608797
• Lead Sponsor: Kessler Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-23
• Study Start: 2024-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training	Learning and memory training	Computer based cognitive training delivered remotely via Zoom Health
sham comparator	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

Name	Time	Method
California Learning Verbal Test III	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

Name	Time	Method
Ecological Memory Simulations	Secondary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States