Multiple Sclerosis, ProgressiveNCT02301247
Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
A study testing Memory retraining exercises in people with Multiple Sclerosis, Progressive and Cognition - Other, run by Kessler Foundation at 1 site in United States.
Trial summary
This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide Class I evidence in support of or in refute of the efficacy of the modified Story Memory Technique (mSMT) in persons with progressive MS, with outcome measured through three mechanisms: (1) a traditional neuropsychological… Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Multiple Sclerosis, Progressive, Cognition - Other, Memory Impairment
- What is being tested?
- Memory retraining exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 2 Apr 2017
- 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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between the ages of 30 and 59
- diagnosed with Progressive Multiple Sclerosis
- have visual acuity of better then 20/60 in worse eye
Who cannot join
- has a prior stroke or neurological injury/disease (brain tumor, epilepsy, traumatic brain injury).
- has a history of psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).
- currently taking medications such as: steroids, benzodiazepines, and neuroleptics. .
- difficulty with vision, eyesight worse then 20/60, or has diminished sight in visual field, double vision, or nystagmus.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide Class I evidence in support of or in refute of the efficacy of the modified Story Memory Technique (mSMT) in persons with progressive MS, with outcome measured through three mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning (AGF) examining the impact of the treatment on daily activities, and (3) an optional functional magnetic resonance imaging (fMRI) scan.
Read the detailed description
There is a clear unmet need in the clinical care of persons with Progressive MS - there are no treatments for memory dysfunction with demonstrated efficacy in persons with progressive disease. This is despite the fact that cognitive impairment is a major contributor to unemployment and decreased functional status in MS and memory deficits are a major source of such disability. The investigator recent RCT's demonstrated the modified Story Memory Technique (mSMT) to be effective for improving new learning and memory in individuals with MS, demonstrating efficacy across three realms of functioning, objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in MS. However, treatment efficacy was not adequately tested in the progressive MS population. This is a major limitation due to the fact that progressive MS carries with it major cognitive difficulties, of which learning and memory are one of the most common. The currently proposed RCT will address this limitation. The investigators will use methodologically vigorous research design to provide Class I evidence in support of or in refute of the efficacy of the mSMT in persons with progressive MS, with outcome measured through three mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning (AGF) examining the impact of the treatment on daily activities and (3) an optional functional magnetic resonance imaging (fMRI) scan. Both groups will undergo baseline, immediate follow-up, and 3-month follow-up assessments
Thus, the current study will objectively evaluate the clinical utility of the mSMT to improve new learning and memory in individuals with progressive MS with documented deficits in this area. This protocol has been previously utilized in a Relapsing-Remitting MS sample, yielding exceptional outcome data. Pilot data in a small sample of progressive MS patients is promising. The investigators will also increase the generalizability and real life application of assessment techniques by assessing outcome following cognitive retraining with more global measures of everyday life. Finally, the long-term efficacy of the mSMT will be evaluated in progressive MS through the inclusion of a 3-month follow-up assessment. Given the absence of any treatment for impaired learning and memory in progressive patients, the results of the present RCT will have a significant impact on symptom management and quality of life for persons with Progressive MS.
- Being tested
- Memory retraining exercises, Placebo control memory exercises
- Keywords
- Multiple Sclerosis, Progressive, cognition, memory, treatment
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory retraining exercisesBehavioural
Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Placebo control memory exercisesBehavioural
Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions). Receives: Behavioral: Memory retraining exercises |
| Placebo | Placebo comparator | The placebo group will receive placebo control memory exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions). Receives: Behavioral: Placebo control memory exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on standardized neuropsychological tests of memory
Measured: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Secondary outcomes (3)
Change in scores on self-report of emotional functioning, measured via questionnaire
Measured: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Change in scores on self-report of memory functioning, measured via questionnaire
Measured: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Change in scores on self-report of quality of life, measured via questionnaire
Measured: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion2 Apr 2017
- Study completion2 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, ProgressiveStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- International Progressive MS Alliance
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
- Investigators
- Matthew R Weiner, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301247
- Sponsor's protocol ID
- R-839-14
- Status last verified
- Jun 2017
- First submitted
- 17 Nov 2014
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- 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
- Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT02301247
- Acronym / sponsor ID
- R-839-14
- Keywords
- Multiple Sclerosis, Progressive, cognition, memory, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- International Progressive MS Alliance
- Study start
- Nov 2014
- Primary completion
- 2 Apr 2017 (actual)
- Study completion
- 2 Apr 2017 (actual)
- First posted
- 25 Nov 2014 (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.
This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide Class I evidence in support of or in refute of the efficacy of the modified Story Memory Technique (mSMT) in persons with progressive MS, with outcome measured through three mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning (AGF) examining the impact of the treatment on daily activities, and (3) an optional functional magnetic resonance imaging (fMRI) scan.
Detailed description
There is a clear unmet need in the clinical care of persons with Progressive MS - there are no treatments for memory dysfunction with demonstrated efficacy in persons with progressive disease. This is despite the fact that cognitive impairment is a major contributor to unemployment and decreased functional status in MS and memory deficits are a major source of such disability. The investigator recent RCT's demonstrated the modified Story Memory Technique (mSMT) to be effective for improving new learning and memory in individuals with MS, demonstrating efficacy across three realms of functioning, objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in MS. However, treatment efficacy was not adequately tested in the progressive MS population. This is a major limitation due to the fact that progressive MS carries with it major cognitive difficulties, of which learning and memory are one of the most common. The currently proposed RCT will address this limitation. The investigators will use methodologically vigorous research design to provide Class I evidence in support of or in refute of the efficacy of the mSMT in persons with progressive MS, with outcome measured through three mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning (AGF) examining the impact of the treatment on daily activities and (3) an optional functional magnetic resonance imaging (fMRI) scan. Both groups will undergo baseline, immediate follow-up, and 3-month follow-up assessments
Thus, the current study will objectively evaluate the clinical utility of the mSMT to improve new learning and memory in individuals with progressive MS with documented deficits in this area. This protocol has been previously utilized in a Relapsing-Remitting MS sample, yielding exceptional outcome data. Pilot data in a small sample of progressive MS patients is promising. The investigators will also increase the generalizability and real life application of assessment techniques by assessing outcome following cognitive retraining with more global measures of everyday life. Finally, the long-term efficacy of the mSMT will be evaluated in progressive MS through the inclusion of a 3-month follow-up assessment. Given the absence of any treatment for impaired learning and memory in progressive patients, the results of the present RCT will have a significant impact on symptom management and quality of life for persons with Progressive MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Memory retraining exercisesThe experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions). |
| Placebo | Placebo comparator | Behavioral: Placebo control memory exercisesThe placebo group will receive placebo control memory exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions). |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between the ages of 30 and 59
- diagnosed with Progressive Multiple Sclerosis
- have visual acuity of better then 20/60 in worse eye
Key exclusion criteria (4 listed)
- has a prior stroke or neurological injury/disease (brain tumor, epilepsy, traumatic brain injury).
- has a history of psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).
- currently taking medications such as: steroids, benzodiazepines, and neuroleptics. .
- difficulty with vision, eyesight worse then 20/60, or has diminished sight in visual field, double vision, or nystagmus.
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 |
|---|---|---|
| Memory retraining exercisesMemory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). | Behavioural | Experimental Group |
| Placebo control memory exercisesPlacebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). | Behavioural | Placebo |
Primary outcome
Change in scores on standardized neuropsychological tests of memory
Time frame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
3 secondary outcomes
Change in scores on self-report of emotional functioning, measured via questionnaire
Time frame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Change in scores on self-report of memory functioning, measured via questionnaire
Time frame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Change in scores on self-report of quality of life, measured via questionnaire
Time frame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
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.
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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.
Matthew R Weiner study director
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 Memory retraining exercises in people with Multiple Sclerosis, Progressive and Cognition - Other, 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 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.
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. 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?
Change in scores on standardized neuropsychological tests of memory (time frame: Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention). 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; AzTrials last refreshed its copy on 31 Oct 2026.