Multiple SclerosisSMENCT03206034
Stylistic Memory Enhancement
A study testing Stylistic Memory Enhancement in people with Multiple Sclerosis, run by Kessler Foundation.
Trial summary
Impairments in higher level cognitive processing, such as new learning and memory, are common in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including occupational and social functioning. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Stylistic Memory Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 31 Dec 2015
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically definite MS between the ages of 18 and 59. Participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension.
Who cannot join
- History of alcohol or drug abuse/dependence,
- Major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than MS.
- Corticosteroid use within the last month prior to the participation.
- Less than 1 month post most recent exacerbation.
About this study
Impairments in higher level cognitive processing, such as new learning and memory, are common in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing. The objective of the study is to test the efficacy of the SME in an MS population.
- Conditions
- Multiple Sclerosis
- Being tested
- Stylistic Memory Enhancement
- Keywords
- Memory, Cognition
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stylistic Memory EnhancementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The experimental group will meet with a study team member twice a week for 4 weeks (8 sessions) and receive memory strategy training. Receives: Behavioral: Stylistic Memory Enhancement |
| Control | Placebo comparator | The control group participants will meet with a study team member twice a week for 4 weeks (8 sessions) and receive control memory exercises. Receives: Behavioral: Stylistic Memory Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test (CVLT-II- Total learning
Measure of change in new learning
Measured: Baseline and post-intervention (5 weeks between testing sessions)
Secondary outcomes (1)
Memory Functioning Questionnaire
Measure of change in Self-report of everyday memory functioning
Measured: Baseline and post-intervention ( 5 weeks between testing sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Mar 2013
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Double blind placebo controlled randomized control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206034
- Sponsor's protocol ID
- E-769-13
- Acronym
- SME
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stylistic Memory Enhancement
- ClinicalTrials.gov ID
- NCT03206034
- Acronym / sponsor ID
- SME / E-769-13
- Conditions
- Multiple Sclerosis
- Keywords
- Memory, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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.
Impairments in higher level cognitive processing, such as new learning and memory, are common in Multiple Sclerosis (MS) and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing. The objective of the study is to test the efficacy of the SME in an MS population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind placebo controlled randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Stylistic Memory EnhancementThe experimental group will meet with a study team member twice a week for 4 weeks (8 sessions) and receive memory strategy training. |
| Control | Placebo comparator | Behavioral: Stylistic Memory EnhancementThe control group participants will meet with a study team member twice a week for 4 weeks (8 sessions) and receive control memory exercises. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically definite MS between the ages of 18 and 59. Participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension.
Key exclusion criteria (4 listed)
- History of alcohol or drug abuse/dependence,
- Major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than MS.
- Corticosteroid use within the last month prior to the participation.
- Less than 1 month post most recent exacerbation.
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 |
|---|---|---|
| Stylistic Memory Enhancement | Behavioural | Control, Treatment |
Primary outcome
California Verbal Learning Test (CVLT-II- Total learning
Time frame: Baseline and post-intervention (5 weeks between testing sessions)
Measure of change in new learning
1 secondary outcome
Memory Functioning Questionnaire
Time frame: Baseline and post-intervention ( 5 weeks between testing sessions)
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 2 Jul 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stylistic Memory Enhancement in people with Multiple Sclerosis, run by Kessler Foundation.
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 1 inclusion and 4 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
California Verbal Learning Test (CVLT-II- Total learning (time frame: Baseline and post-intervention (5 weeks between testing sessions)). 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 2 Jul 2017.