Multiple SclerosisSTEMNCT03983681
Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
A study testing Strategy-Based Training to Enhance Memory (STEM) in people with Multiple Sclerosis, run by Kessler Foundation at 2 sites in United States.
Trial summary
The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis. 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?
- Strategy-Based Training to Enhance Memory (STEM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2019to 8 Dec 2025
- 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
- Diagnosis of Multiple Sclerosis
- Ability to read and speak English fluently
- Difficulties with learning and memory skills
Who cannot join
- Prior diagnosis of stroke or other neurological injury/disease
- Flare up of symptoms within a month of study participation
- History of significant psychiatric illness (e.g., bipolar disorder, schizophrenia, psychosis) or current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II
- Current significant alcohol or substance abuse
- Taking exclusionary medication (study team will review medications)
- For Optional MRI:
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- 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
2 sites in 1 country.
United States2 sites
Kessler Foundation
East Hanover, New Jersey, 07936
Kessler Rehabilitation Center
Marlton, New Jersey, 08053
About this study
The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis.
Read the detailed description
The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis (MS). The study is designed to research how well this technique can help people with MS improve their memory and their ability to function better in everyday life.
- Conditions
- Multiple Sclerosis
- Being tested
- Strategy-Based Training to Enhance Memory (STEM), Placebo control exercises
- Keywords
- Multiple Sclerosis, MS, Relapsing-Remitting MS, Progressive MS, RRMS, PPMS, SPMS, Primary Progressive, Secondary Progressive
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy-Based Training to Enhance Memory (STEM)Behavioural
Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).
Placebo control exercisesBehavioural
Placebo control memory exercises will be administered for 4 weeks (8 training sessions).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions). Receives: Behavioral: Strategy-Based Training to Enhance Memory (STEM) |
| Control group | Placebo comparator | The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions). Receives: Behavioral: Placebo control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scores on self-report measure of everyday cognition (subjective)
Perceived Deficits Questionnaire
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in scores on self-report measure of everyday cognition (objective)
Ecologic Memory Simulations
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Secondary outcomes (7)
Changes in auditory processing speed
Paced Auditory Serial Edition Test
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in information processing speed
Symbol Digit Modalities Test
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in episodic verbal memory and learning
California Verbal Learning Test - 2nd Edition
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in visuospatial memory
Brief Visuospatial Memory Test - Revised
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in ability in spontaneous production of words
Controlled Oral Word Association Test
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in visual perception
Benton Judgment of Line Orientation
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in executive function
Delis-Kaplan Executive Function System - Sorting
Measured: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 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 posted12 Jun 2019
- Study start26 Sep 2019
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
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
- NCT03983681
- Sponsor's protocol ID
- R-1045-18
- Acronym
- STEM
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2019
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
- ClinicalTrials.gov ID
- NCT03983681
- Acronym / sponsor ID
- STEM / R-1045-18
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Relapsing-Remitting MS, Progressive MS, RRMS, PPMS, SPMS, Primary Progressive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 12 Jun 2019 (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.
The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis.
Detailed description
The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis (MS). The study is designed to research how well this technique can help people with MS improve their memory and their ability to function better in everyday life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Strategy-Based Training to Enhance Memory (STEM)The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions). |
| Control group | Placebo comparator | Behavioral: Placebo control exercisesThe control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Multiple Sclerosis
- Ability to read and speak English fluently
- Difficulties with learning and memory skills
Key exclusion criteria (9 listed)
- Prior diagnosis of stroke or other neurological injury/disease
- Flare up of symptoms within a month of study participation
- History of significant psychiatric illness (e.g., bipolar disorder, schizophrenia, psychosis) or current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II
- Current significant alcohol or substance abuse
- Taking exclusionary medication (study team will review medications)
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 |
|---|---|---|
| Strategy-Based Training to Enhance Memory (STEM)Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions). | Behavioural | Experimental |
| Placebo control exercisesPlacebo control memory exercises will be administered for 4 weeks (8 training sessions). | Behavioural | Control group |
Primary outcome
Changes in scores on self-report measure of everyday cognition (subjective)
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Perceived Deficits Questionnaire
Changes in scores on self-report measure of everyday cognition (objective)
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Ecologic Memory Simulations
7 secondary outcomes
Changes in auditory processing speed
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in information processing speed
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in episodic verbal memory and learning
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in visuospatial memory
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in ability in spontaneous production of words
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in visual perception
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Changes in executive function
Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 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 22 Jul 2026.
- 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.
Nancy D Chiaravalloti, PhD principal investigator
Kessler Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy-Based Training to Enhance Memory (STEM) in people with Multiple Sclerosis, run by Kessler Foundation at 2 sites 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 9 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Changes in scores on self-report measure of everyday cognition (subjective) (time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)). The study lists 2 primary outcomes in all. 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 22 Jul 2026.