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

Sponsor

Kessler Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT04054596

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Cognitive Impairment	Behavioral: SME	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Masking:

Double (Participant, 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STEM The treatment group (TX) will complete 8 sessions of STEM (2 sessions per week for 4 weeks), Sessions are approximately 30-45 minutes long.	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.
No Intervention: Controlled During weeks 2-5, one group will undergo a memory enhancement protocol, used to improve memory functioning in individuals with neurological injuries. The other group will serve as a control group and complete memory exercises with the researcher.

Arm

Intervention/Treatment

Experimental: STEM

The treatment group (TX) will complete 8 sessions of STEM (2 sessions per week for 4 weeks), Sessions are approximately 30-45 minutes long.

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.

No Intervention: Controlled

During weeks 2-5, one group will undergo a memory enhancement protocol, used to improve memory functioning in individuals with neurological injuries. The other group will serve as a control group and complete memory exercises with the researcher.

Outcome Measures

Primary Outcome Measures

Self Report Deficits in Daily Life [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.