Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS (STEM)
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ClinicalTrials.gov Identifier: NCT03983681 |
Recruitment Status :
Recruiting
First Posted : June 12, 2019
Last Update Posted : April 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Behavioral: Strategy-Based Training to Enhance Memory (STEM) Behavioral: Placebo control exercises | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Participants will be blind as to which treatment group they are being placed. Study staff conducting baseline and follow-up assessments will also be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance. |
Primary Purpose: | Treatment |
Official Title: | Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS |
Actual Study Start Date : | September 26, 2019 |
Estimated Primary Completion Date : | February 15, 2024 |
Estimated Study Completion Date : | March 31, 2024 |

Arm | Intervention/treatment |
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Experimental: Experimental
The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
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Behavioral: 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). |
Placebo Comparator: Control group
The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
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Behavioral: Placebo control exercises
Placebo control memory exercises will be administered for 4 weeks (8 training sessions). |
- 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
- 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) ]Paced Auditory Serial Edition Test
- 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) ]Symbol Digit Modalities Test
- 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) ]California Verbal Learning Test - 2nd Edition
- Changes in visuospatial memory [ Time Frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) ]Brief Visuospatial Memory Test - Revised
- 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) ]Controlled Oral Word Association Test
- Changes in visual perception [ Time Frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) ]Benton Judgment of Line Orientation
- Changes in executive function [ Time Frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) ]Delis-Kaplan Executive Function System - Sorting

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Multiple Sclerosis
- Ability to read and speak English fluently
- Difficulties with learning and memory skills
Exclusion Criteria:
- 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983681
Contact: Michael Di Benedetto, MA | 973-324-8391 | mdibenedetto@kesslerfoundation.org |
United States, New Jersey | |
Kessler Foundation | Recruiting |
East Hanover, New Jersey, United States, 07936 | |
Contact: Michael Di Benedetto, MA 973-324-8391 mdibenedetto@kesslerfoundation.org | |
Contact: Nancy Moore, MA 973-324-8450 nbmoore@kesslerfoundation.org | |
Principal Investigator: Nancy D Chiaravalloti, PhD | |
Sub-Investigator: Erica Weber, PhD | |
Sub-Investigator: Ekaterina Dobryakova, PhD | |
Sub-Investigator: Jean Lengenfelder, PhD | |
Sub-Investigator: John DeLuca, PhD | |
Sub-Investigator: Amanda Botticello, PhD | |
Kessler Rehabilitation Center | Recruiting |
Marlton, New Jersey, United States, 08053 | |
Contact: Alyssa Bayley 973-324-3678 abayley@kesslerfoundation.org |
Principal Investigator: | Nancy D Chiaravalloti, PhD | Kessler Foundation |
Responsible Party: | Kessler Foundation |
ClinicalTrials.gov Identifier: | NCT03983681 |
Other Study ID Numbers: |
R-1045-18 |
First Posted: | June 12, 2019 Key Record Dates |
Last Update Posted: | April 6, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Sclerosis MS Relapsing-Remitting MS Progressive MS RRMS |
PPMS SPMS Primary Progressive Secondary Progressive |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |