Improving Learning in Hispanics With TBI or MS

Improving Learning in Hispanics With TBI or MS: A Pilot Trial

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

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)
• Intervention / Treatment: Behavioral: Spanish modified Story Memory Technique (mSMT)

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Arrasate-Mondragón, Spain
    • Recruiting
    • Hospital Aita Menni
    • Contact: Garazi Labayr Isusquiza, PhD; Phone Number: +34 943794411; Email: glabairu@aita-menni.org
    • Contact: Jose Ignacio, MD; Phone Number: +34 943794411; Email: jiquemada@aita-menni.org
• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Recruiting
      • Kessler Foundation
      • Contact: Belinda Washington, BA; Phone Number: 973-324-8440; Email: bwashington@kesslerfoundation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 weeks (between pre- and post testing)

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
• Investigators: Study Director: Nancy Chiaravalloti, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2013
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: memory; cognitive rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Multiple Sclerosis; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R-799-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No