Therapeutic Resources for Attention Improvement With Neuroimaging for TBI

Completed

Conditions studied: Traumatic Brain Injury

In brief

One of the most common symptoms suffered by traumatic brain injury (TBI) patients is disruption in attention. Lack of attention impacts daily life including academic or professional tasks, and interpersonal relationships. The focus of Therapeutic Resources for Attention Improvement with Neuroimaging for Traumatic Brain Injury (TRAIN-TBI) is to investigate the changes in neurological function with special interest in attention after TBI for children ages 8 to 16. This study will be done through advanced neuroimaging procedures, neurocognitive testing, and an online training tool created by The Brain Plasticity Institute. The investigators hypothesize that the training will improve attention in TBI subjects and that the advanced imaging will show corresponding neural connectivity changes, as compared to matched healthy controls.

Key facts

Study ID

NCT02082509

Run by

University of California, San Francisco

People needed

26

Starts

2014-03-01

Expected to finish

2015-03-01

Last updated by the study team

2018-12-04

Who can join

Age: 8 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• (TBI Only) Sustained a blunt TBI at least 1 month prior to enrollment date
• (TBI Only) Currently experiencing at least 1 post-concussive symptom at the time of enrollment
• Ages 8-16
• Must be capable of giving assent
• Must have parental or legal guardian capable of giving informed consent

You may not qualify if…

• (TBI Only) Injury is less than 1 month from enrollment
• (TBI Only) At time of enrollment, subject does not endorse any post-concussive symptoms
• Younger than 8 years old or older than 16 years old
• Pregnancy
• Pre-injury neurological diagnosis
• Pre-injury diagnosis of an Axis I or Axis II psychiatric disorder other than mild depression
• Pre-injury diagnosis of ADD/ADHD
• Pre-injury use of psychotropic medication (including ADD/ADHD medications like Ritalin and Adderall), except for a stable regimen of antidepressants
• Any metal in the body/contraindications for MRI/MEG
• Patient weight >350 pounds due to weight limit of MR scanner
• Hypotensive episode or CT/MR evidence of cerebral ischemia after trauma
• Hemicraniectomy for cerebral swelling
• Surgical evacuation of intra-axial lesions such as contusions/hematomas
• Subjects requiring phenytoin within one week of testing session
• Prisoners
• Non-native English speaker (neurocognitive tests not validated for non-English speakers)
• Visual, auditory, and/or motor impairments that would interfere with cognitive testing
• Current or past drug abuse

Where it is running

• UCSF Mission Bay — San Francisco, California, United States

Full record on ClinicalTrials.gov

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