Improving Learning in Hispanics With TBI or MS

TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03453125
• Other study ID #: R-799-13
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2013
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2021
• Source: Kessler Foundation
• Contact: Denise Krch, PhD
• Phone: 973-324-8392
• Email: dkrch[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Multiple Sclerosis
• TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)

Intervention

Behavioral:
• Spanish modified Story Memory Technique (mSMT)

Locations

Country	Name	City	State
Spain	Hospital Aita Menni	Arrasate-Mondragón
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)