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

Multiple Sclerosis Clinical Trial

— STEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983681
• Other study ID #: R-1045-18
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Kessler Foundation
• Contact: Michael Di Benedetto, MA
• Phone: 973-324-8391
• Email: mdibenedetto[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey
United States	Kessler Rehabilitation Center	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)