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Completed

NCT Number: NCT03983681

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

The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation, East Hanover, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strategy-Based Training to Enhance Memory (STEM)

Behavioral

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

Placebo control exercises

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Acronym: STEM

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2019
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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