Modified Story Memory Technique (mSMT) in Persons With TBI

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056312
• Other study ID #: R-926-16
• Status: Completed
• Phase: N/A
• Start date: June 29, 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

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 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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