Therapeutic Resources for Attention Improvement With Neuroimaging for TBI

NCT02082509 | Completed DMC

• 1 other identifier: TRAIN-TBI
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Post-Concussive Symptoms; Brain Imaging; Cognition

Outcome Measures

Primary Outcomes (1)

• Change in neural connectivity following an attention-based cognitive training program called "TAPAT"

  We hypothesize that advanced imaging techniques will allow us to visualize and understand disrupted attention networks (taken before the online training) and how these attention networks recover (as measured after the training). Such imaging methods include: diffusion tensor imaging (DTI, sensitive to the structural integrity of white matter tracks), resting-state functional MRI (rs-fMRI, sensitive to spontaneous fluctuations in blood-oxygen-level-dependent (BOLD) signal due to neurological disease), and magnetoencephalography (MEG, combined with MRI data, detects magnetic fluctuations caused by neuronal firing which produces excellent temporal resolution). We will compare these patterns of neural connectivity of those with TBI to those without (between-subjects) as well as assess individual differences from before and after the TAPAT training (within-subjects)

  2 months after enrollment

Secondary Outcomes (2)

• Improvement of attention measures via online training program (TAPAT)

  2 months after enrollment

• Improvement of overall cognitive functioning

  2 months after enrollment

Study Arms (2)

Traumatic Brain Injury (TBI)

Patient who have sustained a TBI over 1 month prior to enrollment, and endorse at least 1 post-concussive symptom at the time of enrollment.

Healthy Controls (no TBI)

Subjects who match the TBI group's demographic characteristics, except that they have not sustained a TBI and they are otherwise physically and mentally healthy.

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with TBI will be recruited from the Bay Area Concussion and Head Injury Program at UCSF or referred to us by colleagues. Healthy controls will be recruited via flyers and referred to us.

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Mission Bay

San Francisco, California, 94158, United States

Location

Related Publications (4)

• Tarapore PE, Findlay AM, Lahue SC, Lee H, Honma SM, Mizuiri D, Luks TL, Manley GT, Nagarajan SS, Mukherjee P. Resting state magnetoencephalography functional connectivity in traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1306-16. doi: 10.3171/2013.3.JNS12398. Epub 2013 Apr 19.

  PMID: 23600939 BACKGROUND

• Van Vleet TM, DeGutis JM. Cross-training in hemispatial neglect: auditory sustained attention training ameliorates visual attention deficits. Cortex. 2013 Mar;49(3):679-90. doi: 10.1016/j.cortex.2012.03.020. Epub 2012 Apr 9.

  PMID: 22578712 BACKGROUND

• Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.

  PMID: 19220558 BACKGROUND

• Hayes EA, Warrier CM, Nicol TG, Zecker SG, Kraus N. Neural plasticity following auditory training in children with learning problems. Clin Neurophysiol. 2003 Apr;114(4):673-84. doi: 10.1016/s1388-2457(02)00414-5.

  PMID: 12686276 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Pratik Mukherjee, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

US (1)