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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Strategy-Based Training to Enhance Memory (STEM); Behavioral: Placebo control exercises

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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).	Behavioral: Placebo control exercises; Placebo control memory exercises will be administered for 4 weeks (8 training sessions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in scores on self-report measure of everyday cognition (subjective)	Perceived Deficits Questionnaire	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	Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in auditory processing speed	Paced Auditory Serial Edition Test	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	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	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	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	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	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	Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Nancy D Chiaravalloti, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; RRMS; MS; SPMS; Relapsing-Remitting MS; Secondary Progressive; PPMS; Progressive MS; Primary Progressive
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: R-1045-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No