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Improving Learning in Hispanics With TBI or MS

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ClinicalTrials.gov Identifier: NCT03453125
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : July 3, 2018
Sponsor:
Collaborators:
Hospital Aita-Menni, Arrasate-Mondragon, Spain
Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
Information provided by (Responsible Party):
Denise Krch, Kessler Foundation

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

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis) Behavioral: Spanish modified Story Memory Technique (mSMT) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Learning in Hispanics With TBI or MS: A Pilot Trial
Actual Study Start Date : September 25, 2013
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Spanish mSMT Experimental Treatment
Administered by computer and paper and pencil.
Behavioral: Spanish modified Story Memory Technique (mSMT)
Active Comparator: Spanish mSMT Control Treatment
Administered by computer and paper and pencil.
Behavioral: Spanish modified Story Memory Technique (mSMT)



Primary Outcome Measures :
  1. Total learning post-treatment (covarying for baseline performance) [ Time Frame: 7 weeks (between pre- and post testing) ]
    Comparison between treatment and control groups on post-treatment Hopkins Verbal Learning Test (HVLT) learning score, covarying for baseline HVLT performance.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453125


Contacts
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Contact: Denise Krch, PhD 973-324-8392 dkrch@kesslerfoundation.org
Contact: Belinda Washington, BA 973-324-8446 bwashington@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
East Hanover, New Jersey, United States, 07936
Contact: Denise Krch, PhD    973-324-8392    dkrch@kesslerfoundation.org   
Contact: Belinda Washington, BA    973-324-8440    bwashington@kesslerfoundation.org   
Spain
Hospital Aita Menni Recruiting
Arrasate-Mondragón, Spain
Contact: Garazi Labayr Isusquiza, PhD    +34 943794411    glabairu@aita-menni.org   
Contact: Jose Ignacio, MD    +34 943794411    jiquemada@aita-menni.org   
Sponsors and Collaborators
Kessler Foundation
Hospital Aita-Menni, Arrasate-Mondragon, Spain
Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
Investigators
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Study Director: Nancy Chiaravalloti, PhD Kessler Foundation

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Responsible Party: Denise Krch, Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03453125     History of Changes
Other Study ID Numbers: R-799-13
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Denise Krch, Kessler Foundation:
cognitive rehabilitation
memory

Additional relevant MeSH terms:
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Multiple Sclerosis
Brain Injuries
Brain Injuries, Traumatic
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries