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
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Behavioral: Brain Training Program 1 Behavioral: Brain Training Program 2||Phase 2|
link to clinical trials methods paper
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
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
|United States, Texas|
|Center for BrainHealth|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Daniel Krawcyzk, Ph.D.||University of Texas|