- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054596
Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI (STEM)
February 13, 2024 updated by: Nancy Chiaravalloti, Kessler Foundation
Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI: A Randomized Clinical Trial
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nancy Moore, MA
- Phone Number: 973-324-8450
- Email: nmoore@kesslerfoundation.org
Study Contact Backup
- Name: Belinda Washington, BA
- Phone Number: 973-324-8446
- Email: bwashington@kesslerfoundation.org
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 07936
- Recruiting
- Kessler Foundation
-
Contact:
- Belinda Washington, B.A.
- Phone Number: 973-324-3528
- Email: bwashington@kesslerfoundation.org
-
Contact:
- Nancy Moore, MA
- Phone Number: 973-342-8450
- Email: nmoore@kesslerfoundation.org
-
Principal Investigator:
- Nancy Chiaravalloti, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Chiaravalloti, PhD, Kessler Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Estimated)
March 31, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
June 18, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-993-17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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