Modified Story Memory Technique (mSMT) in Persons With TBI

Not Applicable

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT04056312
• Lead Sponsor: Kessler Foundation

Brief Summary

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).

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 Timeline

• Study Start: 2016-06-29
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
California Verbal Learning Test	Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later	Change on scores on memory tests will be assessed using the California Verbal Learning Test
The Traumatic Brain Injury-Quality of Life Scale	Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later	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).

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States