Cognitive Impairment in Multiple SclerosisNCT01978574
Intellectual Enrichment to Build Cognitive Reserve in MS
A study testing Intellectual Enrichment daily activities and Intellectual Enrichment documentary videos in people with Cognitive Impairment in Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Cognitive Impairment in Multiple Sclerosis
- What is being tested?
- Intellectual Enrichment daily activities and Intellectual Enrichment documentary videos
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2013to 1 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 25-65
- MS duration >5 years
- read and speak English fluently
Who cannot join
- 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
Show all 10Show fewer
- history of schizophrenia or bipolar disorder
- pregnant
- currently taking steroids, benzodiazepines, and/or neuroleptics
- do not speak English as primary language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Intellectual Enrichment to Build Cognitive Reserve in Multiple Sclerosis
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.
- Being tested
- Intellectual Enrichment daily activities, Intellectual Enrichment documentary videos
- Keywords
- Cognitive reserve, intellectual enrichment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellectual Enrichment daily activitiesBehavioural
A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).
Intellectual Enrichment documentary videosBehavioural
Also called Placebo control condition
Participants watch daily documentary videos.
| Study group | Role | What they receive |
|---|---|---|
| Documentary videos | Active comparator | In the placebo control condition, participants watch daily videos. Receives: Behavioral: Intellectual Enrichment documentary videos |
| Intellectual Enrichment | Experimental | Daily activities that encourage intellectual enrichment, including games, reading/writing, and hobby activities. Receives: Behavioral: Intellectual Enrichment daily activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall
Measured: Baseline and 13 weeks
Secondary outcomes (1)
Change from Baseline in Beck Depression Inventory
Measured: Baseline and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study start1 Jun 2013
- Primary completion1 Jun 2014
- Study completion1 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment in Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Victoria M Leavitt, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978574
- Sponsor's protocol ID
- NMSS-PP1854
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2013
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Intellectual Enrichment to Build Cognitive Reserve in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01978574
- Acronym / sponsor ID
- NMSS-PP1854
- Keywords
- Cognitive reserve, intellectual enrichment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Jun 2014 (actual)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Documentary videos | Active comparator | Behavioral: Intellectual Enrichment documentary videosIn the placebo control condition, participants watch daily videos. |
| Intellectual Enrichment | Experimental | Behavioral: Intellectual Enrichment daily activitiesDaily activities that encourage intellectual enrichment, including games, reading/writing, and hobby activities. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 25-65
- MS duration >5 years
- read and speak English fluently
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intellectual Enrichment daily activitiesA daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control). | Behavioural | Intellectual Enrichment |
| Intellectual Enrichment documentary videosAlso: Placebo control conditionParticipants watch daily documentary videos. | Behavioural | Documentary videos |
Primary outcome
Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall
Time frame: Baseline and 13 weeks
1 secondary outcome
Change from Baseline in Beck Depression Inventory
Time frame: Baseline and 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria M Leavitt, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intellectual Enrichment daily activities and Intellectual Enrichment documentary videos in people with Cognitive Impairment in Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall (time frame: Baseline and 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.