Brain Training to Enhance Frontal Lobe Reasoning

Traumatic Brain Injury Clinical Trial

Official title:

Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552473
• Other study ID #: STU 032011-191
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2012
• Last updated: October 24, 2016
• Start date: March 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

link to clinical trials methods paper

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for BrainHealth	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at Dallas	University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Neuropsychological changes from baseline to 10 weeks and 3 months post-training
Secondary	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.	Neuropsychological changes from baseline to 10 weeks and 3 months post-training

External Links

•   Center for BrainHealth