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OpenTrials
Completed

NCT Number: NCT04054596

Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI

The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with a Traumatic Brian Injury (TBI). The study is designed to research how well this technique can help people with TBI improve their memory and their ability to function better in everyday life

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

About this study

Impairments in higher level cognitive processing, such as new learning and memory, are common in Traumatic Brain Injury (TBI)and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In order to participate in this study I must meet the following requirements:

  • I am between the ages of 18-65.
  • I have had a traumatic brain injury (TBI) at least 1 year ago.
  • I can read and speak English fluently.
  • I have difficulties with learning and memory skills.

Exclusion criteria

  • I have had a prior stroke or neurological injury/disease other than TBI.
  • I have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
  • I have a significant alcohol or drug abuse history (inpatient Treatment).
  • I am taking certain medications that might exclude me from the research. The study team will review my medications with me.

Treatment and study plan

SME

Behavioral

The treatment group (TX) will complete 8 sessions of SME (2 sessions per week for 4 weeks), de-signed to teach the concepts of SG, SL and RP and the application of these techniques in daily life. Sessions are approximately 30-45 minutes long.

Primary outcomes

  1. Self Report Deficits in Daily Life

    Time frame: 5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

    Perceived Deficits Questionnaire215

    • •20 items; evaluates everyday situations in which cognition has a role
    • •Cronbach's Alpha (lower bound reliability) = .93

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI: A Randomized Clinical Trial

Acronym: STEM

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2019
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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