NCT04056312

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-06-29
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2019-08-14
• Last updated: 2023-01-18

Locations

1 site across 1 country: United States