Clinical trial NCT04054596: Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Cognitive Impairment
Keywords: Traumatic Brain Injury
Cognitive Impairment
Intervention
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2019-08-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self Report Deficits in Daily Life
timeFrame: 5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Nancy Chiaravalloti, PhD
role: PRINCIPAL_INVESTIGATOR
References: