Cognitive Impairment in Multiple Sclerosis Clinical Trial
Official title:
A Randomized Controlled Trial of Intellectual Enrichment to Build Cognitive Reserve in Multiple Sclerosis
| NCT number | NCT01978574 |
| Other study ID # | NMSS-PP1854 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 1, 2013 |
| Est. completion date | June 1, 2014 |
| Verified date | February 2020 |
| Source | Kessler Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | June 1, 2014 |
| Est. primary completion date | June 1, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Kessler Foundation | West Orange | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Kessler Foundation | National Multiple Sclerosis Society |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change from Baseline in fMRI task-related BOLD activation pattern | A neural pattern of fMRI BOLD activation indicating cerebral efficiency will be assessed at baseline and follow-up. | Baseline and 13 weeks | |
| Other | Change from Baseline in fMRI-derived functional connectivity | A neural pattern of fMRI functional connectivity will be assessed at baseline and follow-up. | Baseline and 13 weeks | |
| Primary | Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall | Baseline and 13 weeks | ||
| Secondary | Change from Baseline in Beck Depression Inventory | Baseline and 13 weeks |