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Clinical Trials/NCT04054596
NCT04054596
Completed
Not Applicable

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

Kessler Foundation1 site in 1 country80 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Kessler Foundation
Enrollment
80
Locations
1
Primary Endpoint
Self Report Deficits in Daily Life
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
July 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Nancy Chiaravalloti

Director of NNL & TBI

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • In order to participate in this study I must meet the following requirements:
  • I am between the ages of 18-
  • 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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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