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

NCT ID: NCT04054596

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2024-07-31

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.

Conditions

Traumatic Brain Injury; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SME

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Nancy Chiaravalloti

Director of NNL & TBI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Chiaravalloti, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

E-993-17

Identifier Type: -

Identifier Source: org_study_id