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Brain Training to Enhance Frontal Lobe Reasoning

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ClinicalTrials.gov Identifier: NCT01552473
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Brain Training Program 1 Behavioral: Brain Training Program 2 Phase 2

Detailed Description:

link to clinical trials methods paper

http://trialsjournal.biomedcentral.com/track/pdf/10.1186/1745-6215-14-29?site=trialsjournal.biomedcentral.com


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI
Study Start Date : March 2012
Primary Completion Date : July 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Neuropsychological changes [ Time Frame: Neuropsychological changes from baseline to 10 weeks and 3 months post-training ]
    To examine short-term effects of treatment on cognition and real-life outcomes including psychological health, resilience, depressive symptoms, and symptoms of stress, in soldiers and civilians with TBI. Participants will undergo neuropsychological testing post-training (10 weeks), as well as 3-months post-training.


Secondary Outcome Measures :
  1. Brain connectivity and activation changes [ Time Frame: Neuropsychological changes from baseline to 10 weeks and 3 months post-training ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552473


Locations
United States, Texas
Center for BrainHealth
Dallas, Texas, United States, 75235
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:
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
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: May 2016

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

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