Improving Learning in Hispanics With TBI or MS

Kessler Foundation

Status: Unknown

Conditions: TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)

Treatments: Behavioral: Spanish modified Story Memory Technique (mSMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03453125

R-799-13

Details and patient eligibility

About

The goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective.

Full description

A pilot study will be conducted to carry out this validation and resolve any methodological concerns in the translated protocol. 20 Spanish-speaking Hispanics at least one year post-traumatic brain injury (TBI) and 20 Spanish-speaking Hispanics with multiple sclerosis (MS), both with an objective deficit in learning and memory will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Subjects are randomly assigned to either the experimental or control groups. Experimental and control treatments includes two 45-60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on an objective measure of learning and memory.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between the ages of 18 and 65
• Spanish is my dominant language, and I have had a traumatic brain injury or I have multiple sclerosis.

Exclusion criteria

• Participants with major depressive disorder, schizophrenia, bipolar disorder I or II
• MS subjects: Individuals with a history of head injury, stroke, seizures, or any other significant neurological history will not be included in the study.
• TBI subjects: Individuals must have sustained a TBI at least one year prior to enrollment in the study protocol. Individuals with a history of significant neurological insult other than TBI (e.g. premorbid epilepsy, multiple sclerosis, Alzheimer's disease) will not be included in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Spanish mSMT Experimental Treatment

Experimental group

Description:

Administered by computer and paper and pencil.

Treatment:

Behavioral: Spanish modified Story Memory Technique (mSMT)

Spanish mSMT Control Treatment

Active Comparator group

Description:

Administered by computer and paper and pencil.

Treatment:

Behavioral: Spanish modified Story Memory Technique (mSMT)