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

NCT06608797 | Recruiting

• 1 other identifier: E-1259-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

learning, memory, cognitive training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Training

EXPERIMENTAL

Computer based cognitive training delivered remotely via Zoom Health

Behavioral: Learning and memory training

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).

Behavioral: Sham Comparator

Interventions

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).

Training

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).

sham comparator

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English as primary language
• Diagnosis of multiple sclerosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Educational Status; Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Silvana L Costa Research Scientist, PhD

CONTACT

973 324 8458; scosta@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 23, 2024
• Study Start: September 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)