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CompletedNCT03983681STEMUpdated Jul 22, 2026

Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS

An interventional study of Strategy-Based Training to Enhance Memory (STEM) and Placebo control exercises in Multiple Sclerosis, sponsored by Kessler Foundation. Completed at 2 sites in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Multiple Sclerosis
  • MS
  • Relapsing-Remitting MS
  • Progressive MS
  • RRMS
  • PPMS
  • SPMS
  • Primary Progressive
  • Secondary Progressive
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 81 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Experimental

    The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

    Behavioral: Strategy-Based Training to Enhance Memory (STEM)

  • Placebo comparator
    Control group

    The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

    Behavioral: Placebo control exercises

Interventions

  • BehavioralStrategy-Based Training to Enhance Memory (STEM)

    Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).

  • BehavioralPlacebo control exercises

    Placebo control memory exercises will be administered for 4 weeks (8 training sessions).

06

What researchers measure

Primary outcomes

  1. Changes in scores on self-report measure of everyday cognition (subjective)

    Perceived Deficits Questionnaire

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

  2. Changes in scores on self-report measure of everyday cognition (objective)

    Ecologic Memory Simulations

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

Secondary outcomes

  1. Changes in auditory processing speed

    Paced Auditory Serial Edition Test

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

  2. Changes in information processing speed

    Symbol Digit Modalities Test

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

  3. Changes in episodic verbal memory and learning

    California Verbal Learning Test - 2nd Edition

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

  4. Changes in visuospatial memory

    Brief Visuospatial Memory Test - Revised

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

  5. Changes in ability in spontaneous production of words

    Controlled Oral Word Association Test

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

  6. Changes in visual perception

    Benton Judgment of Line Orientation

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

  7. Changes in executive function

    Delis-Kaplan Executive Function System - Sorting

    Time frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

07

Study locations

2 sites
  • Kessler Foundation
    East Hanover, New Jersey 07936, United States
  • Kessler Rehabilitation Center
    Marlton, New Jersey 08053, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03983681
Lead sponsor
Kessler Foundation
Responsible party
Nancy Chiaravalloti (Director, Kessler Foundation) — Principal investigator
First posted
Jun 12, 2019
Start date
Sep 26, 2019
Primary completion
Dec 8, 2025
Completion
Dec 8, 2025
Last update
Jul 22, 2026

Study contacts

Nancy D Chiaravalloti, PhD
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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