Modified Story Memory Technique (mSMT) in Persons With TBI

Kessler Foundation

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Group Memory retraining exercises; Behavioral: Placebo controlled group memory exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT04056312

R-926-16

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Group memory retraining

Experimental group

Description:

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

Treatment:

Behavioral: Group Memory retraining exercises

Placebo

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Placebo controlled group memory exercise training