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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01552473
Other study ID # STU 032011-191
Secondary ID
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
Health authority
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

Study Design


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
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