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

NCT03370224 | Enrolling By Invitation

• 1 other identifier: R-990-17
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Mild Cognitive Impairment

Keywords

Memory; Learning; Cognition; Treatment

Outcome Measures

Primary Outcomes (1)

• Change in scores on standardized neuropsychological tests of memory using the California Verbal Learning Test

  California Verbal Learning Test

  Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12, 24 months, and 6 years post-intervention.

Secondary Outcomes (3)

• Change in scores on self-report of emotional functioning, measured via the Chicago multiscale depression inventory

  Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 ,24 months and 6 years post-intervention]

• Change in scores on self-report of memory functioning, measured via questionnaire by the Memory Functioning Questionnaire

  Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12, 24 months and 6 years post-intervention]

• Change in scores on self-report of quality of life, measured via the SF-12

  Scores will be assessed at five time-points: Baseline (week 1), immediately post-intervention (week 7) and 6, 12 and 24 months and 6 years post-intervention]

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Memory retraining exercises BEHAVIORAL

Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Experimental Group

Placebo control memory exercises BEHAVIORAL

Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• older than 65
• primary language is English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nancy D Chiaravalloti, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuropsychology and Neuroscience Research

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: November 1, 2017
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)