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Completed

NCT Number: NCT04056312

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Memory retraining exercises

Behavioral

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

Placebo controlled group memory exercise training

Behavioral

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

Primary outcomes

  1. California Verbal Learning Test

    Time frame: 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

  2. The Traumatic Brain Injury-Quality of Life Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2019
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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