Modified Story Memory Technique (mSMT) in Persons With TBI

A Randomized Clinical Trial Examining The Efficacy of The Group Administered Modified Story Memory Technique (mSMT) in Persons With TBI

The current RCT is designed to:

1. test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
2. 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
3. evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
4. 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).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Group Memory retraining exercises; Behavioral: Placebo controlled group memory exercise training

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group memory retraining; Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.	Behavioral: Group Memory retraining exercises; Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Placebo Comparator: Placebo; Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.	Behavioral: Placebo controlled group memory exercise training; Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
California Verbal Learning Test	Change on scores on memory tests will be assessed using the California Verbal Learning Test	Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
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).	Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Study Chair: Richard Green, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2016
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: memory; cognition; learning; traumatic brain injury; treatment and therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R-926-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No