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

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: Cognitive Impairment; Traumatic Brain Injury
• Intervention / Treatment: Behavioral: SME

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

• 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

• United States
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 weeks from baseline (short term follow-up) and 7 months from baseline (long term follow-up)

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Nancy Chiaravalloti, PhD, Kessler Foundation

Study record dates

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

• Keywords: Cognitive Impairment; Intervention; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Brain Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction
• 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