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OpenTrials
Completed

NCT Number: NCT01978574

Intellectual Enrichment to Build Cognitive Reserve in MS

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intellectual Enrichment daily activities

Behavioral

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

Intellectual Enrichment documentary videos

Behavioral

Participants watch daily documentary videos.

Other names: Placebo control condition

Primary outcomes

  1. 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 outcomes

  1. Change from Baseline in Beck Depression Inventory

    Time frame: Baseline and 13 weeks

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2013
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.