Modified Story Memory Technique (mSMT) in Persons With TBI

NCT ID: NCT04056312

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-29
• Study Completion Date: 2022-06-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group memory retraining

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

Group Type: EXPERIMENTAL

Group Memory retraining exercises

Intervention Type: BEHAVIORAL

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo controlled group memory exercise training

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Nancy Chiaravalloti

Director NNL & TBI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Green, PhD

Role: STUDY_CHAIR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

R-926-16

Identifier Type: -

Identifier Source: org_study_id