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Intellectual Enrichment to Build Cognitive Reserve in MS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01978574
Enrollment
9
Registered
2013-11-07
Start date
2013-06-01
Completion date
2014-06-01
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment in Multiple Sclerosis

Keywords

Cognitive reserve, intellectual enrichment

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.

Interventions

BEHAVIORALIntellectual Enrichment daily activities

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

BEHAVIORALIntellectual Enrichment documentary videos

Participants watch daily documentary videos.

Sponsors

National Multiple Sclerosis Society
CollaboratorOTHER
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed RecallBaseline and 13 weeks

Secondary

MeasureTime frame
Change from Baseline in Beck Depression InventoryBaseline and 13 weeks

Other

MeasureTime frameDescription
Change from Baseline in fMRI task-related BOLD activation patternBaseline and 13 weeksA neural pattern of fMRI BOLD activation indicating cerebral efficiency will be assessed at baseline and follow-up.
Change from Baseline in fMRI-derived functional connectivityBaseline and 13 weeksA neural pattern of fMRI functional connectivity will be assessed at baseline and follow-up.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026