Modified Story Memory Technique (mSMT) in Persons With TBI

Completed · Not applicable · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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).

Key facts

Study ID

NCT04056312

Run by

Kessler Foundation

People needed

45

Starts

2016-06-29

Expected to finish

2022-06-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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