Improving Learning in Hispanics With TBI or MS

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

Detailed Description
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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.

Official Title
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Improving Learning in Hispanics With TBI or MS: A Pilot Trial

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

Intervention / Treatment
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* Behavioral: Spanish modified Story Memory Technique (mSMT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spanish mSMT Experimental Treatment<br>Administered by computer and paper and pencil. | Behavioral: Spanish modified Story Memory Technique (mSMT)<br> <br> |
| Active Comparator: Spanish mSMT Control Treatment<br>Administered by computer and paper and pencil. | Behavioral: Spanish modified Story Memory Technique (mSMT)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total learning post-treatment (covarying for baseline performance) | Comparison between treatment and control groups on post-treatment Hopkins Verbal Learning Test (HVLT) learning score, covarying for baseline HVLT performance. | 7 weeks (between pre- and post testing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive rehabilitation, memory