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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 : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983681


Contacts
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Contact: Michael Di Benedetto, MA 973-324-8391 mdibenedetto@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Michael Di Benedetto, MA    973-324-8391    mdibenedetto@kesslerfoundation.org   
Contact: Nancy Moore, MA    973-324-8450    nbmoore@kesslerfoundation.org   
Principal Investigator: Nancy D Chiaravalloti, PhD         
Sub-Investigator: Erica Weber, PhD         
Sub-Investigator: Ekaterina Dobryakova, PhD         
Sub-Investigator: Jean Lengenfelder, PhD         
Sub-Investigator: John DeLuca, PhD         
Sub-Investigator: Amanda Botticello, PhD         
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Nancy D Chiaravalloti, PhD Kessler Foundation

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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT03983681     History of Changes
Other Study ID Numbers: R-1045-18
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kessler Foundation:
Multiple Sclerosis
MS
Relapsing-Remitting MS
Progressive MS
RRMS
PPMS
SPMS
Primary Progressive
Secondary Progressive

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases