Recruiting

Observational Study

Sponsor:

Kessler Foundation

Code:

NCT03453125

Conditions

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

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Spanish modified Story Memory Technique (mSMT)

Study Details

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.

Conditions

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

Study ID

NCT03453125

Start date

Sep 25, 2013

Status verified date

Dec, 2021

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spanish mSMT Experimental Treatment

Administered by computer and paper and pencil.

active comparator: Spanish mSMT Control Treatment

Administered by computer and paper and pencil.

Interventions

Spanish modified Story Memory Technique (mSMT)

Primary outcome measure

  • Total learning post-treatment (covarying for baseline performance) [ Time Frame: 7 weeks (between pre- and post testing) ]

Central Contacts and Locations

Central contacts

Denise Krch, PhD

973-324-8392dkrch@kesslerfoundation.org

Belinda Washington, BA

973-324-8446bwashington@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Denise Krch, PhD

973-324-8392dkrch@kesslerfoundation.org

Belinda Washington, BA

973-324-8440bwashington@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Jan 12, 2022

Last verified

Dec, 2021

Keywords

  • cognitive rehabilitation
  • memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2022-01-12.