Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS (STEM)
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strategy-Based Training to Enhance Memory (STEM)
Placebo control exercises
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MS, Relapsing-Remitting MS, Progressive MS, RRMS, PPMS, SPMS, Primary Progressive, Secondary Progressive
Eligibility Criteria
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
Sites / Locations
- Kessler FoundationRecruiting
- Kessler Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Control group
Arm Description
The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
Outcomes
Primary Outcome Measures
Changes in scores on self-report measure of everyday cognition (subjective)
Perceived Deficits Questionnaire
Changes in scores on self-report measure of everyday cognition (objective)
Ecologic Memory Simulations
Secondary Outcome Measures
Changes in auditory processing speed
Paced Auditory Serial Edition Test
Changes in information processing speed
Symbol Digit Modalities Test
Changes in episodic verbal memory and learning
California Verbal Learning Test - 2nd Edition
Changes in visuospatial memory
Brief Visuospatial Memory Test - Revised
Changes in ability in spontaneous production of words
Controlled Oral Word Association Test
Changes in visual perception
Benton Judgment of Line Orientation
Changes in executive function
Delis-Kaplan Executive Function System - Sorting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03983681
Brief Title
Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
Acronym
STEM
Official Title
Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, MS, Relapsing-Remitting MS, Progressive MS, RRMS, PPMS, SPMS, Primary Progressive, Secondary Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
Intervention Type
Behavioral
Intervention Name(s)
Strategy-Based Training to Enhance Memory (STEM)
Intervention Description
Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).
Intervention Type
Behavioral
Intervention Name(s)
Placebo control exercises
Intervention Description
Placebo control memory exercises will be administered for 4 weeks (8 training sessions).
Primary Outcome Measure Information:
Title
Changes in scores on self-report measure of everyday cognition (subjective)
Description
Perceived Deficits Questionnaire
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Title
Changes in scores on self-report measure of everyday cognition (objective)
Description
Ecologic Memory Simulations
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Secondary Outcome Measure Information:
Title
Changes in auditory processing speed
Description
Paced Auditory Serial Edition Test
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Title
Changes in information processing speed
Description
Symbol Digit Modalities Test
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Title
Changes in episodic verbal memory and learning
Description
California Verbal Learning Test - 2nd Edition
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Title
Changes in visuospatial memory
Description
Brief Visuospatial Memory Test - Revised
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Title
Changes in ability in spontaneous production of words
Description
Controlled Oral Word Association Test
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Title
Changes in visual perception
Description
Benton Judgment of Line Orientation
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Title
Changes in executive function
Description
Delis-Kaplan Executive Function System - Sorting
Time Frame
Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Di Benedetto, MA
Phone
973-324-8391
Email
mdibenedetto@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy D Chiaravalloti, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Di Benedetto, MA
Phone
973-324-8391
Email
mdibenedetto@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy Moore, MA
Phone
973-324-8450
Email
nbmoore@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy D Chiaravalloti, PhD
First Name & Middle Initial & Last Name & Degree
Erica Weber, PhD
First Name & Middle Initial & Last Name & Degree
Ekaterina Dobryakova, PhD
First Name & Middle Initial & Last Name & Degree
Jean Lengenfelder, PhD
First Name & Middle Initial & Last Name & Degree
John DeLuca, PhD
First Name & Middle Initial & Last Name & Degree
Amanda Botticello, PhD
Facility Name
Kessler Rehabilitation Center
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Bayley
Phone
973-324-3678
Email
abayley@kesslerfoundation.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
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