Improving Learning in Hispanics With TBI or MS

Sponsor
Kessler Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT03453125
Collaborator
Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico (Other)
40
2
2
108.2
20
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Spanish modified Story Memory Technique (mSMT)
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Sep 25, 2013
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Total learning post-treatment (covarying for baseline performance) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kessler Foundation East Hanover New Jersey United States 07936
2 Hospital Aita Menni Arrasate-Mondragón Spain

Sponsors and Collaborators

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

Investigators

  • Study Director: Nancy Chiaravalloti, PhD, Kessler Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Denise Krch, Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT03453125
Other Study ID Numbers:
  • R-799-13
First Posted:
Mar 5, 2018
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Denise Krch, Research Scientist, Kessler Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022