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Application of the Modified Story Memory Technique (mSMT)© to Aging

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ClinicalTrials.gov Identifier: NCT03370224
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation

Brief Summary:
This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide Class I evidence in support of or in refute of the efficacy of the modified Story Memory Technique (mSMT) in healthy aging (HA)and in persons with mild cognitive impairment (MCI). Outcomes will be measured through three mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning (AGF) examining the impact of the treatment on daily activities, and (3) an optional functional magnetic resonance imaging (fMRI) scan.

Condition or disease Intervention/treatment Phase
Aging Mild Cognitive Impairment Behavioral: Memory retraining exercises Behavioral: Placebo control memory exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of the Modified Story Memory Technique (mSMT)© to Aging
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Experimental Group
The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Behavioral: Memory retraining exercises
Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Placebo Comparator: Placebo
The placebo group will receive placebo control memory exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Behavioral: Placebo control memory exercises
Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).




Primary Outcome Measures :
  1. Change in scores on standardized neuropsychological tests of memory using the California Verbal Learning Test [ Time Frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 and 24 months post-intervention] ]
    California Verbal Learning Test


Secondary Outcome Measures :
  1. Change in scores on self-report of emotional functioning, measured via the Chicago multiscale depression inventory [ Time Frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 and 24 months post-intervention] ]
    Chicago multiscale depression inventory

  2. Change in scores on self-report of memory functioning, measured via questionnaire by the Memory Functioning Questionnaire [ Time Frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 and 24 months post-intervention] ]
    Memory Functioning Questionnaire

  3. Change in scores on self-report of quality of life, measured via the SF-12 [ Time Frame: Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 and 24 months post-intervention] ]
    SF -12



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • older than 65
  • primary language is English.

Exclusion Criteria:

  • diagnosis of any neurological condition (Alzheimer's disease, dementia, stroke, multiple sclerosis, Brain Injury, Parkinson's disease, etc.).
  • diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
  • abuse of illicit drug within the past 6 months.

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): NCT03370224


Contacts
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Contact: Nancy B Moore, MA 973-324-8450 nbmoore@kesslerfoundation.org
Contact: Angela A Smith, MA 973-324-8448 asmith@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Nancy B Moore, MA    973-324-8450    nbmoore@kesslerfoundation.org   
Contact: Angela A Smith, MA    973-324-8448    asmith@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Nancy D Chiaravalloti, PhD Kessler Foundation
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Responsible Party: Nancy Chiaravalloti, Director, Neuropsychology and Neuroscience Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03370224    
Other Study ID Numbers: R-990-17
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 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 Nancy Chiaravalloti, Kessler Foundation:
Memory
Learning
Cognition
Treatment
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders