Intellectual Enrichment to Build Cognitive Reserve in MS

NCT ID: NCT01978574

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-01

Study Completion Date

2014-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Impairment in Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Documentary videos

In the placebo control condition, participants watch daily videos.

Group Type ACTIVE_COMPARATOR

Intellectual Enrichment documentary videos

Intervention Type BEHAVIORAL

Participants watch daily documentary videos.

Intellectual Enrichment

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

Group Type EXPERIMENTAL

Intellectual Enrichment daily activities

Intervention Type BEHAVIORAL

A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).

Interventions

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Intellectual Enrichment daily activities

A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).

Intervention Type BEHAVIORAL

Intellectual Enrichment documentary videos

Participants watch daily documentary videos.

Intervention Type BEHAVIORAL

Other Intervention Names

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Placebo control condition

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria M Leavitt, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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NMSS-PP1854

Identifier Type: -

Identifier Source: org_study_id

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