AgingNCT03370224
Application of the Modified Story Memory Technique (mSMT)© to Aging
A study testing Memory retraining exercises in people with Aging and Mild Cognitive Impairment, 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 healthy aging (HA)and in persons with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Mild Cognitive 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
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- older than 65
- primary language is English.
Who cannot join
- diagnosis of any neurological condition (Alzheimer's disease, dementia, stroke, multiple sclerosis, Brain Injury, Parkinson's disease, etc.).
- diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
- abuse of illicit drug within the past 6 months.
- For optional MRI
- pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids [cochlear implants]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
- dental implants
- left handed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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 healthy aging (HA)and in persons with mild cognitive impairment (MCI). Outcomes will be 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
Studies conducted at Kessler Foundation (KF) have demonstrated the modified Story Memory Technique (mSMT) to be effective for improving new learning in individuals with MS and TBI. Efficacy of the individualized mSMT has been clearly demonstrated across three realms of functioning, objective behavior, brain functioning and everyday life in multiple RCTs with both MS and TBI samples. This convincing data provides Class I evidence supporting the efficacy of the individual mSMT for improving new learning and memory in MS with documentation of long-lasting treatment effects on both standardized learning tests and neuroimaging. Current work with the mSMT is focusing on a group administration format, with a RCT funded by the Department of Defense.
Ongoing work in healthy aging (HA), led by George Rebok, PhD at the Johns Hopkins School of Public Health, has applied cognitive retraining to older healthy adults. Multiple, strong rationale for pursuing such applications of cognitive rehabilitation include the fact that the 65 and older population is growing (an estimated 20% of population (72 million) will be 65 and older by 2030), cognitive decline is most feared aspect of growing older, drug trial results addressing this challenge have been disappointing and, most importantly, cognitive impairments heavily affect the aging population. Specifically, 1 in 4 adults 70 years or older have a cognitive impairment without dementia and roughly 5.3 million people in the U.S. have Alzheimer's disease. Rebok and colleagues have applied Speed of Processing Training to a large cohort of healthy older adults (age 65+) and found a 33-48% risk reduction of dementia onset 10 years post treatment. These encouraging results suggest that providing cognitively enhancing treatments prior to the onset of dementia may in fact stave off the dementia process and provide older individuals with more years free of cognitive deficit.
Given the substantial success of the mSMT in improving new learning and memory functioning in persons with TBI and MS, we seek to apply the mSMT to an aging population with multiple aims.
Aim 1. Examine the efficacy of the mSMT to increase learning and memory abilities in older adults with mild cognitive impairment (MCI) and older adults with no signs of cognitive impairment (healthy aging group: HA).
Aim 2. Examine the long term impact of the mSMT on new learning and memory abilities one and two years post-intervention for both the MCI group and the HA group.
Aim 3. Examine the impact of early cognitive enhancement with the mSMT on measures of daily life functioning and overall quality of life immediately posttreatment and at each follow-up assessment.
Aim 4. Examine the neural correlates during encoding and retrieval associated with early cognitive enhancement from the mSMT immediately post-treatment and at each follow-up assessment
To achieve these goals, we will recruit 40 individuals over the age of 65 to participate in the study. Each participant will undergo baseline cognitive assessment. Based on the assessment results, he / she will be allocated to the HA block or the MCI block. Within each block, participants will be randomized to a treatment group or a placebo control group. The treatment group will undergo 10 sessions of the mSMT, while the placebo control group will undergo 10 sessions of memory exercises. We have used this placebo condition in multiple randomized clinical trials in the past, with success. Repeat assessments will then occur within one week of completing treatment, 6 months after completing treatment, one year after completing treatment, 2 years after completing treatment and 6 years after treatment. Each assessment will evaluate new learning and memory abilities as well as multiple other aspects of cognitive functioning through a neuropsychological assessment (NP). Participants will also complete an assessment of global functioning (AGF) which evaluates cognitive functioning in daily life. In addition, we will collect neuroimaging data on a subsample of participants willing and able to complete imaging procedures
- Conditions
- Aging, Mild Cognitive Impairment
- Being tested
- Memory retraining exercises, Placebo control memory exercises
- Keywords
- Memory, Learning, Cognition, Treatment
- Medical subject headings
- Cognitive Dysfunction
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 using the California Verbal Learning Test
California Verbal Learning Test
Measured: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12, 24 months, and 6 years post-intervention.
Secondary outcomes (3)
Change in scores on self-report of emotional functioning, measured via the Chicago multiscale depression inventory
Chicago multiscale depression inventory
Measured: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 ,24 months and 6 years post-intervention]
Change in scores on self-report of memory functioning, measured via questionnaire by the Memory Functioning Questionnaire
Memory Functioning Questionnaire
Measured: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12, 24 months and 6 years post-intervention]
Change in scores on self-report of quality of life, measured via the SF-12
SF -12
Measured: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 and 24 months and 6 years post-intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
- Investigators
- Nancy D Chiaravalloti, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370224
- Sponsor's protocol ID
- R-990-17
- Status last verified
- Aug 2025
- First submitted
- 7 Dec 2017
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Modified Story Memory Technique (mSMT)© to Aging
- ClinicalTrials.gov ID
- NCT03370224
- Acronym / sponsor ID
- R-990-17
- Conditions
- Aging, Mild Cognitive Impairment
- Keywords
- Memory, Learning, Cognition, Treatment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 12 Dec 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.
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 healthy aging (HA)and in persons with mild cognitive impairment (MCI). Outcomes will be 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
Studies conducted at Kessler Foundation (KF) have demonstrated the modified Story Memory Technique (mSMT) to be effective for improving new learning in individuals with MS and TBI. Efficacy of the individualized mSMT has been clearly demonstrated across three realms of functioning, objective behavior, brain functioning and everyday life in multiple RCTs with both MS and TBI samples. This convincing data provides Class I evidence supporting the efficacy of the individual mSMT for improving new learning and memory in MS with documentation of long-lasting treatment effects on both standardized learning tests and neuroimaging. Current work with the mSMT is focusing on a group administration format, with a RCT funded by the Department of Defense.
Ongoing work in healthy aging (HA), led by George Rebok, PhD at the Johns Hopkins School of Public Health, has applied cognitive retraining to older healthy adults. Multiple, strong rationale for pursuing such applications of cognitive rehabilitation include the fact that the 65 and older population is growing (an estimated 20% of population (72 million) will be 65 and older by 2030), cognitive decline is most feared aspect of growing older, drug trial results addressing this challenge have been disappointing and, most importantly, cognitive impairments heavily affect the aging population. Specifically, 1 in 4 adults 70 years or older have a cognitive impairment without dementia and roughly 5.3 million people in the U.S. have Alzheimer's disease. Rebok and colleagues have applied Speed of Processing Training to a large cohort of healthy older adults (age 65+) and found a 33-48% risk reduction of dementia onset 10 years post treatment. These encouraging results suggest that providing cognitively enhancing treatments prior to the onset of dementia may in fact stave off the dementia process and provide older individuals with more years free of cognitive deficit.
Given the substantial success of the mSMT in improving new learning and memory functioning in persons with TBI and MS, we seek to apply the mSMT to an aging population with multiple aims.
Aim 1. Examine the efficacy of the mSMT to increase learning and memory abilities in older adults with mild cognitive impairment (MCI) and older adults with no signs of cognitive impairment (healthy aging group: HA).
Aim 2. Examine the long term impact of the mSMT on new learning and memory abilities one and two years post-intervention for both the MCI group and the HA group.
Aim 3. Examine the impact of early cognitive enhancement with the mSMT on measures of daily life functioning and overall quality of life immediately posttreatment and at each follow-up assessment.
Aim 4. Examine the neural correlates during encoding and retrieval associated with early cognitive enhancement from the mSMT immediately post-treatment and at each follow-up assessment
To achieve these goals, we will recruit 40 individuals over the age of 65 to participate in the study. Each participant will undergo baseline cognitive assessment. Based on the assessment results, he / she will be allocated to the HA block or the MCI block. Within each block, participants will be randomized to a treatment group or a placebo control group. The treatment group will undergo 10 sessions of the mSMT, while the placebo control group will undergo 10 sessions of memory exercises. We have used this placebo condition in multiple randomized clinical trials in the past, with success. Repeat assessments will then occur within one week of completing treatment, 6 months after completing treatment, one year after completing treatment, 2 years after completing treatment and 6 years after treatment. Each assessment will evaluate new learning and memory abilities as well as multiple other aspects of cognitive functioning through a neuropsychological assessment (NP). Participants will also complete an assessment of global functioning (AGF) which evaluates cognitive functioning in daily life. In addition, we will collect neuroimaging data on a subsample of participants willing and able to complete imaging procedures
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 |
|---|---|---|
| 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
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- older than 65
- primary language is English.
Key exclusion criteria (7 listed)
- diagnosis of any neurological condition (Alzheimer's disease, dementia, stroke, multiple sclerosis, Brain Injury, Parkinson's disease, etc.).
- diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
- abuse of illicit drug within the past 6 months.
- For optional MRI
- pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids [cochlear implants]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
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 using the California Verbal Learning Test
Time frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12, 24 months, and 6 years post-intervention.
California Verbal Learning Test
3 secondary outcomes
Change in scores on self-report of emotional functioning, measured via the Chicago multiscale depression inventory
Time frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 ,24 months and 6 years post-intervention]
Change in scores on self-report of memory functioning, measured via questionnaire by the Memory Functioning Questionnaire
Time frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12, 24 months and 6 years post-intervention]
Change in scores on self-report of quality of life, measured via the SF-12
Time frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 and 24 months and 6 years post-intervention]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- 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.
Nancy D Chiaravalloti, 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 Memory retraining exercises in people with Aging and Mild Cognitive Impairment, 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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 using the California Verbal Learning Test (time frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12, 24 months, and 6 years 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 11 Aug 2025.