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Modified Story Memory Technique (mSMT) in Persons With TBI

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Memory retraining exercises
Placebo controlled group memory exercise training
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 memory, learning, cognition, traumatic brain injury, treatment and therapy

Eligibility Criteria

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

Inclusion Criteria:

  • I am between the ages of 18-65.
  • I have had a Traumatic Brain Injury at least one year ago.
  • I can read and speak English fluently.
  • I have difficulties with learning and memory skills.

Exclusion Criteria:

  • I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications.
  • I have had a prior stroke or neurological injury/disease other than a traumatic brain injury.
  • I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
  • I have unstable or uncontrolled seizures.
  • I have a significant alcohol or drug abuse history.

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group memory retraining

Placebo

Arm Description

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

Outcomes

Primary Outcome Measures

California Verbal Learning Test
Change on scores on memory tests will be assessed using the California Verbal Learning Test
The Traumatic Brain Injury-Quality of Life Scale
Self-reports of emotional functioning, memory functioning and quality of life on The Traumatic Brain Injury-Quality of Life Scale, which measures these constructs. DVs will be change on the Depression subscale (range: 0-40; lower score is better) and Cognition scale (range: 0-40; higher score is better).

Secondary Outcome Measures

Full Information

First Posted
August 15, 2017
Last Updated
January 16, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04056312
Brief Title
Modified Story Memory Technique (mSMT) in Persons With TBI
Official Title
A Randomized Clinical Trial Examining The Efficacy of The Group Administered Modified Story Memory Technique (mSMT) in Persons With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

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 current RCT is designed to: test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other evaluate the changes in brain functioning following treatment with the mSMT via fMRI and evaluate the long-term effects of the treatment protocol. To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).
Detailed Description
Outcome measures will assess objective memory abilities, everyday memory abilities and patterns of cerebral activation during learning. A long-term follow-up assessment will be conducted, designed to measure the impact of the mSMT 3 months following treatment completion. Alternate forms will be utilized wherever available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
memory, learning, cognition, traumatic brain injury, treatment and therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group memory retraining
Arm Type
Experimental
Arm Description
Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Intervention Type
Behavioral
Intervention Name(s)
Group Memory retraining exercises
Intervention Description
Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Intervention Type
Behavioral
Intervention Name(s)
Placebo controlled group memory exercise training
Intervention Description
Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Primary Outcome Measure Information:
Title
California Verbal Learning Test
Description
Change on scores on memory tests will be assessed using the California Verbal Learning Test
Time Frame
Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
Title
The Traumatic Brain Injury-Quality of Life Scale
Description
Self-reports of emotional functioning, memory functioning and quality of life on The Traumatic Brain Injury-Quality of Life Scale, which measures these constructs. DVs will be change on the Depression subscale (range: 0-40; lower score is better) and Cognition scale (range: 0-40; higher score is better).
Time Frame
Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later

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: I am between the ages of 18-65. I have had a Traumatic Brain Injury at least one year ago. I can read and speak English fluently. I have difficulties with learning and memory skills. Exclusion Criteria: I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications. I have had a prior stroke or neurological injury/disease other than a traumatic brain injury. I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II. I have unstable or uncontrolled seizures. I have a significant alcohol or drug abuse history.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Green, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

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Modified Story Memory Technique (mSMT) in Persons With TBI

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