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

Primary Purpose

Traumatic Brain Injury, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SME
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Cognitive Impairment, Intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STEM

Controlled

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2019
Last Updated
January 16, 2023
Sponsor
Kessler Foundation
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT04054596
Brief Title
Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Cognitive Impairment
Keywords
Traumatic Brain Injury, Cognitive Impairment, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEM
Arm Type
Experimental
Arm Description
The treatment group (TX) will complete 8 sessions of STEM (2 sessions per week for 4 weeks), Sessions are approximately 30-45 minutes long.
Arm Title
Controlled
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SME
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self Report Deficits in Daily Life
Description
Perceived Deficits Questionnaire215 •20 items; evaluates everyday situations in which cognition has a role •Cronbach's Alpha (lower bound reliability) = .93
Time Frame
5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Belinda Washington, BA
Phone
973-324-8446
Email
bwashington@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Moore, MA
Phone
973-324-8450
Email
nmoore@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Chiaravalloti, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belinda Washington, B.A.
Phone
973-324-3528
Email
bwashington@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy Moore, MA
Phone
973-342-8450
Email
nmoore@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Nancy Chiaravalloti, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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