Clinical trial NCT04056312: Modified Story Memory Technique (mSMT) in Persons With TBI
Official title: A Randomized Clinical Trial Examining The Efficacy of The Group Administered Modified Story Memory Technique (mSMT) in Persons With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: memory
learning
cognition
traumatic brain injury
treatment and therapy
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: California Verbal Learning Test
timeFrame: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
measure: The Traumatic Brain Injury-Quality of Life Scale
timeFrame: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Richard Green, PhD
role: STUDY_CHAIR
References: