Brain Training to Enhance Frontal Lobe Reasoning

This study is currently recruiting participants.
Verified January 2013 by The University of Texas at Dallas
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
The University of Texas at Dallas
ClinicalTrials.gov Identifier:
NCT01552473
First received: March 6, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).


Condition Intervention Phase
Traumatic Brain Injury
Behavioral: Brain Training Program 1
Behavioral: Brain Training Program 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI

Resource links provided by NLM:


Further study details as provided by The University of Texas at Dallas:

Primary Outcome Measures:
  • Neuropsychological changes [ Time Frame: Neuropsychological changes from baseline to 10 weeks and 3 months post-training ] [ Designated as safety issue: No ]
    To examine short-term effects of treatment on cognition and real-life outcomes in soldiers and civilians with TBI. Participant will undergo neuropsychological testing post-training (10 weeks), as well as 3-months post-training.


Secondary Outcome Measures:
  • Brain connectivity and activation changes [ Time Frame: Neuropsychological changes from baseline to 10 weeks and 3 months post-training ] [ Designated as safety issue: No ]
    To examine any connectivity or activation changes in the brain as a result of treatment on fMRI measures. fMRI data will be taken post-training (10 weeks) as well as 3-months post-testing.


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brain Training Program 1
Training Program focusing on providing educational information of cognitive issues related to TBI
Behavioral: Brain Training Program 1
The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities.
Experimental: Brain Training Program 2
Program focuses on strategies to address cognitive issues following TBI
Behavioral: Brain Training Program 2
The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19-65 years of age
  • Sustained a traumatic brain injury at least 6 months previously
  • Comprehend simple instructions, perform tasks and take part in intervention
  • Read, speak and comprehend English
  • Participate in tasks involving motor abilities such as use of at least one arm or hand

Exclusion Criteria:

  • Not proficient in reading, comprehending or speaking English
  • Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder
  • Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy
  • Women who are pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552473

Contacts
Contact: Stephanie Tuthill, M.A.,CCC-SLP 972-883-3252 s.tuthill@utdallas.edu
Contact: Molly Keebler, M.A.,CCC-SLP 972-883-3412 molly.keebler@utdallas.edu

Locations
United States, Texas
Center for BrainHealth Recruiting
Dallas, Texas, United States, 75235
Principal Investigator: Daniel Krawczyk, Ph. D.         
Principal Investigator: Sandra Chapman, Ph. D.         
Sub-Investigator: Carlos Marquez de la Plata, Ph. D.         
Sponsors and Collaborators
The University of Texas at Dallas
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Daniel Krawcyzk, Ph.D. University of Texas
  More Information

Additional Information:
No publications provided by The University of Texas at Dallas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT01552473     History of Changes
Other Study ID Numbers: STU 032011-191
Study First Received: March 6, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas at Dallas:
dizziness
TBI
Traumatic Brain Injury
combat related injury
blast injury
concussion
sleep problems
attention problems
memory problems
headaches
OEF
OIF
Veterans
Civilian

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 16, 2014