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

NCT03983681 | Active Not Recruiting DMC

• 1 other identifier: R-1045-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; Relapsing-Remitting MS; Progressive MS; RRMS; PPMS; SPMS; Primary Progressive; Secondary Progressive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Changes in auditory processing speed

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

• Changes in information processing speed

  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

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

• Changes in visuospatial memory

  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

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

Study Arms (2)

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)

Control group

PLACEBO COMPARATOR

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

Behavioral: Placebo control exercises

Interventions

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).

Experimental

Placebo control exercises BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Multiple Sclerosis
• Ability to read and speak English fluently
• Difficulties with learning and memory skills

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (2)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

Kessler Rehabilitation Center

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nancy D Chiaravalloti, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: September 26, 2019
• Primary Completion: September 15, 2025
• Study Completion: September 30, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)