Improving Learning in Hispanics With TBI or MS

NCT ID: NCT03453125

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-25

Study Completion Date

2022-09-30

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Spanish mSMT Experimental Treatment

Administered by computer and paper and pencil.

Group Type EXPERIMENTAL

Spanish modified Story Memory Technique (mSMT)

Intervention Type BEHAVIORAL

Spanish mSMT Control Treatment

Administered by computer and paper and pencil.

Group Type ACTIVE_COMPARATOR

Spanish modified Story Memory Technique (mSMT)

Intervention Type BEHAVIORAL

Interventions

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Spanish modified Story Memory Technique (mSMT)

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico

UNKNOWN

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Denise Krch

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Chiaravalloti, PhD

Role: STUDY_DIRECTOR

Kessler Foundation

Locations

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Kessler Foundation

East Hanover, New Jersey, United States

Site Status RECRUITING

Hospital Aita Menni

Arrasate / Mondragón, , Spain

Site Status RECRUITING

Countries

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United States Spain

Central Contacts

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Denise Krch, PhD

Role: CONTACT

973-324-8392

Belinda Washington, BA

Role: CONTACT

973-324-8446

Facility Contacts

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Denise Krch, PhD

Role: primary

973-324-8392

Belinda Washington, BA

Role: backup

973-324-8440

Garazi Labayr Isusquiza, PhD

Role: primary

+34 943794411

Jose Ignacio, MD

Role: backup

+34 943794411

Other Identifiers

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R-799-13

Identifier Type: -

Identifier Source: org_study_id

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