Intellectual Enrichment to Build Cognitive Reserve in MS

February 19, 2020 updated by: Kessler Foundation

A Randomized Controlled Trial of Intellectual Enrichment to Build Cognitive Reserve in Multiple Sclerosis

Cognitive problems are a primary concern for people with multiple sclerosis. In many cases, people with MS report these issues to be more debilitating than the motor symptoms that are targeted by most treatment strategies. For people with MS, impaired memory and thinking skills can interfere with the ability to function efficiently in multiple professional and personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking skills is a vitally important research priority. We now know that engaging in intellectually enriching activities helps protect against the negative impact of MS disease-related declines in memory and thinking. Such activities contribute to something called 'cognitive reserve,' which serves as a protection against disease-related declines in memory and thinking. Thus far, no one has created a treatment that aims to provide a concentrated 'dose' of intellectual enrichment to build cognitive reserve. The present intervention aims to do precisely this. Here, we have developed a program of enriching activities that are delivered via a personal iPad. This allows for a 12-week 'treatment' that is entirely home-based, while also providing close personal contact between participants and our study personnel, who will communicate daily via emails. Week by week, participants choose from a menu of intellectually enriching activities such that their treatment is dynamic and customizable to fit their interests. The intervention is designed to be fun, as we hope the activities will be incorporated into people's lives beyond the period of the study itself. Given what we already know about the striking benefits of cognitive reserve to protect against disease-related declines in cognitive functioning, we expect to show that treatment with a daily, intense, intellectually enriching schedule of activities results in improved thinking and memory for people with MS. We will also investigate the positive impact of our treatment on the brains of people with MS through brain scans. We expect to see evidence for a shift toward more efficient processing in the brain, changes that translate to improved memory and thinking skills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 25-65
  • MS duration >5 years
  • read and speak English fluently

Exclusion Criteria:

  • currently experiencing an MS exacerbation
  • MS exacerbation within 6 weeks of study start
  • left handed
  • non-MRI compatible: metal in body, claustrophobic
  • history of neurological disorder other than MS
  • history of head injury
  • history of schizophrenia or bipolar disorder
  • pregnant
  • currently taking steroids, benzodiazepines, and/or neuroleptics
  • do not speak English as primary language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Documentary videos
In the placebo control condition, participants watch daily videos.
Behavioral: Intellectual Enrichment documentary videos
Participants watch daily documentary videos.
Other Names:
  • Placebo control condition
Experimental: Intellectual Enrichment
Daily activities that encourage intellectual enrichment, including games, reading/writing, and hobby activities.
Behavioral: Intellectual Enrichment daily activities
A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall
Time Frame: Baseline and 13 weeks
Baseline and 13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Beck Depression Inventory
Time Frame: Baseline and 13 weeks
Baseline and 13 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in fMRI task-related BOLD activation pattern
Time Frame: Baseline and 13 weeks
A neural pattern of fMRI BOLD activation indicating cerebral efficiency will be assessed at baseline and follow-up.
Baseline and 13 weeks
Change from Baseline in fMRI-derived functional connectivity
Time Frame: Baseline and 13 weeks
A neural pattern of fMRI functional connectivity will be assessed at baseline and follow-up.
Baseline and 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

National Multiple Sclerosis Society

Investigators

  • Principal Investigator: Victoria M Leavitt, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMSS-PP1854

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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