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

Sponsor

Kessler Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT03983681

Collaborator

(none)

120

Enrollment

Locations

Arms

54.1

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: Strategy-Based Training to Enhance Memory (STEM) Behavioral: Placebo control exercises	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 26, 2019

Anticipated Primary Completion Date :

Feb 15, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Changes in scores on self-report measure of everyday cognition (subjective) [Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)]
Perceived Deficits Questionnaire
Changes in scores on self-report measure of everyday cognition (objective) [Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)]
Ecologic Memory Simulations

Secondary Outcome Measures

Changes in auditory processing speed [Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)]
Paced Auditory Serial Edition Test
Changes in information processing speed [Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)]
Symbol Digit Modalities Test
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)]
California Verbal Learning Test - 2nd Edition
Changes in visuospatial memory [Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)]
Brief Visuospatial Memory Test - Revised
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)]
Controlled Oral Word Association Test
Changes in visual perception [Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)]
Benton Judgment of Line Orientation
Changes in executive function [Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)]
Delis-Kaplan Executive Function System - Sorting

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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