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Improving Learning in Hispanics With TBI or MS

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03453125
Enrollment
40
Registered
2018-03-05
Start date
2013-09-25
Completion date
2022-09-30
Last updated
2022-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cognitive rehabilitation, memory

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.

Interventions

BEHAVIORALSpanish modified Story Memory Technique (mSMT)

Sponsors

Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
CollaboratorUNKNOWN
Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Spain, United States

Contacts

Primary ContactDenise Krch, PhD
dkrch@kesslerfoundation.org973-324-8392
Backup ContactBelinda Washington, BA
bwashington@kesslerfoundation.org973-324-8446

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026