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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04054596
Acronym
STEM
Enrollment
80
Registered
2019-08-13
Start date
2017-12-01
Completion date
2024-07-31
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Traumatic Brain Injury

Keywords

Traumatic Brain Injury, Cognitive Impairment, Intervention

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.

Interventions

BEHAVIORALSME

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.

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research
CollaboratorFED
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Once enrolled, participants will be randomly assigned to the TX or CTL group via a computerized random number generator coordinated by the statistician, who will not be blinded. Group assignment will be concealed. Both the participant and the examiner conducting the baseline and outcome assessments will be blind to group membership.

Intervention model description

The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with a Traumatic Brian Injury (TBI).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Self Report Deficits in Daily Life5 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026