Recruiting

Cognitive Training

Sponsor:

Kessler Foundation

Code:

NCT06608797

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

Interventions

Learning and memory training

Sham Comparator

Study Details

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 ID

NCT06608797

Start date

Sep 30, 2024

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 65

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

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).

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Silvana L Costa Research Scientist, PhD

973 324 8458scosta@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Silvana M Lopes Costa, PhD

9733248458scosta@kesslerfoundation.org

Emily Fernandez

973-323-3759efernandez@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Feb 21, 2025

Last verified

Feb, 2025

Keywords

  • learning, memory, cognitive training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-02-21.