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

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ClinicalTrials.gov Identifier: NCT04054596
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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 : December 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: 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.
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.



Primary Outcome Measures :
  1. Self Report Deficits in Daily Life [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054596


Contacts
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Contact: Belinda Washington, BA 973-324-8446 bwashington@kesslerfoundation.org
Contact: Nancy Moore, MA 973-324-8450 nmoore@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Belinda Washington, B.A.    973-324-3528    bwashington@kesslerfoundation.org   
Contact: Nancy Moore, MA    973-342-8450    nmoore@kesslerfoundation.org   
Principal Investigator: Nancy Chiaravalloti, PhD         
Sponsors and Collaborators
Kessler Foundation
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Principal Investigator: Nancy Chiaravalloti, PhD Kessler Foundation

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Responsible Party: Nancy Chiaravalloti, Director of NNL & TBI, Kessler Foundation
ClinicalTrials.gov Identifier: NCT04054596     History of Changes
Other Study ID Numbers: E-993-17
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy Chiaravalloti, Kessler Foundation:
Traumatic Brain Injury
Cognitive Impairment
Intervention
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cognition Disorders
Neurocognitive Disorders
Mental Disorders