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

NCT04054596 | Completed

• 1 other identifier: E-993-17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury; Cognitive Impairment

Keywords

Traumatic Brain Injury; Cognitive Impairment; Intervention

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

STEM

EXPERIMENTAL

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

Controlled

NO INTERVENTION

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.

Interventions

SME BEHAVIORAL

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.

STEM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nancy Chiaravalloti, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of NNL & TBI

Model Details: The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with a Traumatic Brian Injury (TBI).

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: August 13, 2019
• Study Start: December 1, 2017
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 20, 2025

Record last verified: 2024-02

Locations

US (1)