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

Traumatic Brain Injury Clinical Trial

— STEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054596
• Other study ID #: E-993-17
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Kessler Foundation
• Contact: Belinda Washington, BA
• Phone: 973-324-8446
• Email: bwashington[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Cognitive Impairment
• Traumatic Brain Injury

Intervention

Behavioral:
• SME
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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Report Deficits in Daily Life	Perceived Deficits Questionnaire215; •20 items; evaluates everyday situations in which cognition has a role; •Cronbach's Alpha (lower bound reliability) = .93	5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)