Improving Learning in Hispanics With TBI or MS
Primary Purpose
TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spanish modified Story Memory Technique (mSMT)
Sponsored by
About this trial
This is an interventional treatment trial for TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis) focused on measuring cognitive rehabilitation, memory
Eligibility 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.
Sites / Locations
- Kessler FoundationRecruiting
- Hospital Aita MenniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spanish mSMT Experimental Treatment
Spanish mSMT Control Treatment
Arm Description
Administered by computer and paper and pencil.
Administered by computer and paper and pencil.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03453125
First Posted
February 21, 2018
Last Updated
December 23, 2021
Sponsor
Kessler Foundation
Collaborators
Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT03453125
Brief Title
Improving Learning in Hispanics With TBI or MS
Official Title
Improving Learning in Hispanics With TBI or MS: A Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2013 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)
Keywords
cognitive rehabilitation, memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spanish mSMT Experimental Treatment
Arm Type
Experimental
Arm Description
Administered by computer and paper and pencil.
Arm Title
Spanish mSMT Control Treatment
Arm Type
Active Comparator
Arm Description
Administered by computer and paper and pencil.
Intervention Type
Behavioral
Intervention Name(s)
Spanish modified Story Memory Technique (mSMT)
Primary Outcome Measure Information:
Title
Total learning post-treatment (covarying for baseline performance)
Description
Comparison between treatment and control groups on post-treatment Hopkins Verbal Learning Test (HVLT) learning score, covarying for baseline HVLT performance.
Time Frame
7 weeks (between pre- and post testing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Krch, PhD
Phone
973-324-8392
Email
dkrch@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Belinda Washington, BA
Phone
973-324-8446
Email
bwashington@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Chiaravalloti, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Krch, PhD
Phone
973-324-8392
Email
dkrch@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Belinda Washington, BA
Phone
973-324-8440
Email
bwashington@kesslerfoundation.org
Facility Name
Hospital Aita Menni
City
Arrasate-Mondragón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garazi Labayr Isusquiza, PhD
Phone
+34 943794411
Email
glabairu@aita-menni.org
First Name & Middle Initial & Last Name & Degree
Jose Ignacio, MD
Phone
+34 943794411
Email
jiquemada@aita-menni.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Improving Learning in Hispanics With TBI or MS
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