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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

Tracking Information
First Submitted Date  ICMJE February 21, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date July 3, 2018
Actual Study Start Date  ICMJE September 25, 2013
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03453125 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Learning in Hispanics With TBI or MS
Official Title  ICMJE Improving Learning in Hispanics With TBI or MS: A Pilot Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)
Intervention  ICMJE Behavioral: Spanish modified Story Memory Technique (mSMT)
Study Arms  ICMJE
  • Experimental: Spanish mSMT Experimental Treatment
    Administered by computer and paper and pencil.
    Intervention: Behavioral: Spanish modified Story Memory Technique (mSMT)
  • Active Comparator: Spanish mSMT Control Treatment
    Administered by computer and paper and pencil.
    Intervention: Behavioral: Spanish modified Story Memory Technique (mSMT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Denise Krch, PhD 973-324-8392 dkrch@kesslerfoundation.org
Contact: Belinda Washington, BA 973-324-8446 bwashington@kesslerfoundation.org
Listed Location Countries  ICMJE Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03453125
Other Study ID Numbers  ICMJE R-799-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Denise Krch, Kessler Foundation
Study Sponsor  ICMJE Kessler Foundation
Collaborators  ICMJE
  • Hospital Aita-Menni, Arrasate-Mondragon, Spain
  • Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
Investigators  ICMJE
Study Director: Nancy Chiaravalloti, PhD Kessler Foundation
PRS Account Kessler Foundation
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP