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Intellectual Enrichment to Build Cognitive Reserve in MS

Primary Purpose

Cognitive Impairment in Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intellectual Enrichment daily activities
Intellectual Enrichment documentary videos
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment in Multiple Sclerosis focused on measuring Cognitive reserve, intellectual enrichment

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Documentary videos

Intellectual Enrichment

Arm Description

In the placebo control condition, participants watch daily videos.

Daily activities that encourage intellectual enrichment, including games, reading/writing, and hobby activities.

Outcomes

Primary Outcome Measures

Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall

Secondary Outcome Measures

Change from Baseline in Beck Depression Inventory

Full Information

First Posted
October 31, 2013
Last Updated
February 19, 2020
Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT01978574
Brief Title
Intellectual Enrichment to Build Cognitive Reserve in MS
Official Title
A Randomized Controlled Trial of Intellectual Enrichment to Build Cognitive Reserve in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
June 1, 2014 (Actual)
Study Completion Date
June 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment in Multiple Sclerosis
Keywords
Cognitive reserve, intellectual enrichment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Documentary videos
Arm Type
Active Comparator
Arm Description
In the placebo control condition, participants watch daily videos.
Arm Title
Intellectual Enrichment
Arm Type
Experimental
Arm Description
Daily activities that encourage intellectual enrichment, including games, reading/writing, and hobby activities.
Intervention Type
Behavioral
Intervention Name(s)
Intellectual Enrichment daily activities
Intervention Description
A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).
Intervention Type
Behavioral
Intervention Name(s)
Intellectual Enrichment documentary videos
Other Intervention Name(s)
Placebo control condition
Intervention Description
Participants watch daily documentary videos.
Primary Outcome Measure Information:
Title
Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall
Time Frame
Baseline and 13 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Beck Depression Inventory
Time Frame
Baseline and 13 weeks
Other Pre-specified Outcome Measures:
Title
Change from Baseline in fMRI task-related BOLD activation pattern
Description
A neural pattern of fMRI BOLD activation indicating cerebral efficiency will be assessed at baseline and follow-up.
Time Frame
Baseline and 13 weeks
Title
Change from Baseline in fMRI-derived functional connectivity
Description
A neural pattern of fMRI functional connectivity will be assessed at baseline and follow-up.
Time Frame
Baseline and 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria M Leavitt, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

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Intellectual Enrichment to Build Cognitive Reserve in MS

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