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

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ClinicalTrials.gov Identifier: NCT03983681
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date February 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Changes in scores on self-report measure of everyday cognition (subjective) [ Time Frame: 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) [ Time Frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) ]
    Ecologic Memory Simulations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Changes in auditory processing speed [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) ]
    Delis-Kaplan Executive Function System - Sorting
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
Changes in neuropsychological assessments of cognitive performance [ Time Frame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) ]
MACFIMS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
Official Title  ICMJE Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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).
  • Behavioral: Placebo control exercises
    Placebo control memory exercises will be administered for 4 weeks (8 training sessions).
Study Arms  ICMJE
  • Experimental: Experimental
    The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
    Intervention: Behavioral: Strategy-Based Training to Enhance Memory (STEM)
  • Placebo Comparator: Control group
    The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).
    Intervention: Behavioral: Placebo control exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date February 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Di Benedetto, MA 973-324-8391 mdibenedetto@kesslerfoundation.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983681
Other Study ID Numbers  ICMJE R-1045-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kessler Foundation
Study Sponsor  ICMJE Kessler Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nancy D Chiaravalloti, PhD Kessler Foundation
PRS Account Kessler Foundation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP