Back to resultsBrain Training to Enhance Frontal Lobe Reasoning
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brain Training Program 1
Brain Training Program 2
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring TBI, Traumatic Brain Injury, combat related injury, blast injury, concussion, sleep problems, attention problems, memory problems, headaches, dizziness, OEF, OIF, Veterans, Civilian
Eligibility 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
Sites / Locations
- Center for BrainHealth
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Brain Training Program 1
Brain Training Program 2
Arm Description
Training Program focusing on providing educational information of cognitive issues related to TBI
Program focuses on strategies to address cognitive issues following TBI
Outcomes
Primary Outcome Measures
Neuropsychological changes
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
Brain connectivity and activation changes
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.
Full Information
NCT ID
NCT01552473
First Posted
March 6, 2012
Last Updated
October 24, 2016
Sponsor
The University of Texas at Dallas
Collaborators
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01552473
Brief Title
Brain Training to Enhance Frontal Lobe Reasoning
Official Title
Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas at Dallas
Collaborators
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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).
Detailed Description
link to clinical trials methods paper
http://trialsjournal.biomedcentral.com/track/pdf/10.1186/1745-6215-14-29?site=trialsjournal.biomedcentral.com
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
TBI, Traumatic Brain Injury, combat related injury, blast injury, concussion, sleep problems, attention problems, memory problems, headaches, dizziness, OEF, OIF, Veterans, Civilian
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brain Training Program 1
Arm Type
Active Comparator
Arm Description
Training Program focusing on providing educational information of cognitive issues related to TBI
Arm Title
Brain Training Program 2
Arm Type
Experimental
Arm Description
Program focuses on strategies to address cognitive issues following TBI
Intervention Type
Behavioral
Intervention Name(s)
Brain Training Program 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brain Training Program 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuropsychological changes
Description
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.
Time Frame
Neuropsychological changes from baseline to 10 weeks and 3 months post-training
Secondary Outcome Measure Information:
Title
Brain connectivity and activation changes
Description
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.
Time Frame
Neuropsychological changes from baseline to 10 weeks and 3 months post-training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Krawcyzk, Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for BrainHealth
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23363480
Citation
Krawczyk DC, Marquez de la Plata C, Schauer GF, Vas AK, Keebler M, Tuthill S, Gardner C, Jantz T, Yu W, Chapman SB. Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol. Trials. 2013 Jan 30;14:29. doi: 10.1186/1745-6215-14-29.
Results Reference
derived
Links:
URL
http://centerforbrainhealth.com
Description
Center for BrainHealth
Learn more about this trial
Brain Training to Enhance Frontal Lobe Reasoning
We'll reach out to this number within 24 hrs