NCT01022307

Brief Summary

The investigators propose to develop quantitative automated lesion detection (QALD) procedures to identify brain damage following traumatic brain injury more accurately than is possible with a normal magnetic resonance imaging (MRI) scans. These procedures require about 1 hour of imaging in an MRI scanner. Subjects will also undergo about 2 hours of cognitive tests. The investigators will compare the results of the cognitive tests with those from MRI scanning to determine what brain regions are responsible for superior performance and for performance decrements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 14, 2016

Completed
Last Updated

January 14, 2016

Status Verified

December 1, 2015

Enrollment Period

5.4 years

First QC Date

May 8, 2009

Results QC Date

December 8, 2015

Last Update Submit

December 8, 2015

Conditions

Keywords

behavioral data acquisitionMRI

Outcome Measures

Primary Outcomes (1)

  • Performance on Trail-making Test, Part B

    z-score based on response time, regressed for age and computer use

    Single session generally several years after TBI depending on time of recruitment of subjects.

Study Arms (2)

Group 1: no history of TBI

184 participants with no history of traumatic brain injury (TBI).

Group 2: with a history of TBI

28 patients with a history of TBI. Most of these patients had suffered mild TBI.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Our targeted population is veterans from OEF/OIF. Other subjects will be recruited as needed to fulfill recruitment targets.

You may qualify if:

  • Control subjects from 18-50.
  • Patients from 18-50 who have suffered TBI.

You may not qualify if:

  • Substance abuse.
  • Irremedial sensory deficits (blindness, deafness).
  • Primary psychiatric disorder.
  • Neurological disease unrelated to TBI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Northern California HCS

Martinez, California, 94553, United States

Location

Related Publications (18)

  • Alho K, Rinne T, Herron TJ, Woods DL. Stimulus-dependent activations and attention-related modulations in the auditory cortex: a meta-analysis of fMRI studies. Hear Res. 2014 Jan;307:29-41. doi: 10.1016/j.heares.2013.08.001. Epub 2013 Aug 11.

    PMID: 23938208BACKGROUND
  • Kang X, Herron TJ, Woods DL. Validation of the anisotropy index ellipsoidal area ratio in diffusion tensor imaging. Magn Reson Imaging. 2010 May;28(4):546-56. doi: 10.1016/j.mri.2009.12.015. Epub 2010 Jan 21.

    PMID: 20096529BACKGROUND
  • Woods DL, Herron TJ, Cate AD, Yund EW, Stecker GC, Rinne T, Kang X. Functional properties of human auditory cortical fields. Front Syst Neurosci. 2010 Dec 3;4:155. doi: 10.3389/fnsys.2010.00155. eCollection 2010.

    PMID: 21160558BACKGROUND
  • Cate AD, Herron TJ, Kang X, Yund EW, Woods DL. Intermodal attention modulates visual processing in dorsal and ventral streams. Neuroimage. 2012 Nov 15;63(3):1295-304. doi: 10.1016/j.neuroimage.2012.08.026. Epub 2012 Aug 16.

    PMID: 22917986BACKGROUND
  • Woods DL, Herron TJ, Cate AD, Kang X, Yund EW. Phonological processing in human auditory cortical fields. Front Hum Neurosci. 2011 Apr 20;5:42. doi: 10.3389/fnhum.2011.00042. eCollection 2011.

    PMID: 21541252BACKGROUND
  • Woods DL, Yund EW, Wyma JM, Ruff R, Herron TJ. Measuring executive function in control subjects and TBI patients with question completion time (QCT). Front Hum Neurosci. 2015 May 19;9:288. doi: 10.3389/fnhum.2015.00288. eCollection 2015.

    PMID: 26042021BACKGROUND
  • Woods DL, Wyma JM, Herron TJ, Yund EW. An improved spatial span test of visuospatial memory. Memory. 2016 Sep;24(8):1142-55. doi: 10.1080/09658211.2015.1076849. Epub 2015 Sep 11.

    PMID: 26357906BACKGROUND
  • Turken AU, Herron TJ, Kang X, O'Connor LE, Sorenson DJ, Baldo JV, Woods DL. Multimodal surface-based morphometry reveals diffuse cortical atrophy in traumatic brain injury. BMC Med Imaging. 2009 Dec 31;9:20. doi: 10.1186/1471-2342-9-20.

  • Kang X, Herron TJ, Cate AD, Yund EW, Woods DL. Hemispherically-unified surface maps of human cerebral cortex: reliability and hemispheric asymmetries. PLoS One. 2012;7(9):e45582. doi: 10.1371/journal.pone.0045582. Epub 2012 Sep 18.

  • Herron TJ, Kang X, Woods DL. Automated measurement of the human corpus callosum using MRI. Front Neuroinform. 2012 Sep 12;6:25. doi: 10.3389/fninf.2012.00025. eCollection 2012.

  • Kang X, Herron TJ, Turken AU, Woods DL. Diffusion properties of cortical and pericortical tissue: regional variations, reliability and methodological issues. Magn Reson Imaging. 2012 Oct;30(8):1111-22. doi: 10.1016/j.mri.2012.04.004. Epub 2012 Jun 12.

  • Kang X, Herron TJ, Woods DL. Regional variation, hemispheric asymmetries and gender differences in pericortical white matter. Neuroimage. 2011 Jun 15;56(4):2011-23. doi: 10.1016/j.neuroimage.2011.03.016. Epub 2011 Mar 22.

  • Whitaker KJ, Kang X, Herron TJ, Woods DL, Robertson LC, Alvarez BD. White matter microstructure throughout the brain correlates with visual imagery in grapheme-color synesthesia. Neuroimage. 2014 Apr 15;90:52-9. doi: 10.1016/j.neuroimage.2013.12.054. Epub 2014 Jan 7.

  • Zhang S, Cate AD, Herron TJ, Kang X, Yund EW, Bao S, Woods DL. Functional and anatomical properties of human visual cortical fields. Vision Res. 2015 Apr;109(Pt A):107-21. doi: 10.1016/j.visres.2015.01.015. Epub 2015 Feb 4.

  • Kang X, Herron TJ, Ettlinger M, Woods DL. Hemispheric asymmetries in cortical and subcortical anatomy. Laterality. 2015;20(6):658-84. doi: 10.1080/1357650X.2015.1032975. Epub 2015 Apr 20.

  • Woods DL, Wyma JM, Herron TJ, Yund EW. The Effects of Aging, Malingering, and Traumatic Brain Injury on Computerized Trail-Making Test Performance. PLoS One. 2015 Jun 10;10(6):e0124345. doi: 10.1371/journal.pone.0124345. eCollection 2015.

  • Woods DL, Wyma JM, Yund EW, Herron TJ, Reed B. Age-related slowing of response selection and production in a visual choice reaction time task. Front Hum Neurosci. 2015 Apr 23;9:193. doi: 10.3389/fnhum.2015.00193. eCollection 2015.

  • Woods DL, Wyma JM, Yund EW, Herron TJ, Reed B. Factors influencing the latency of simple reaction time. Front Hum Neurosci. 2015 Mar 26;9:131. doi: 10.3389/fnhum.2015.00131. eCollection 2015.

Biospecimen

Retention: NONE RETAINED

No biospecimen, only digital data.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
David L. Woods, Chief Clinical Neurophysiology
Organization
VANCHCS

Study Officials

  • David L. Woods, PhD

    VA Northern California HCS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2009

First Posted

December 1, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 14, 2016

Results First Posted

January 14, 2016

Record last verified: 2015-12

Locations