NCT01298557

Brief Summary

The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and that the impaired cortical activation can be detected with magnetoencephalography (MEG), and that the results of these imaging examinations will correlate with neurocognitive status and functional recovery after TBI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

6 years

First QC Date

February 9, 2011

Last Update Submit

November 30, 2018

Conditions

Keywords

Traumatic brain injuryPost-concussive symptomsBrain imagingNeurocognitive testing

Outcome Measures

Primary Outcomes (1)

  • Changes in white matter tract structure

    We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI). We evaluate DTI using 3T and 7T MRI. Participants receive scans at only one time-point.

    up to 4 years following date of injury

Secondary Outcomes (2)

  • Neurocognitive function

    up to 4 years following date of injury

  • Cortical activation

    up to 4 years following date of injury

Study Arms (2)

Traumatic brain injured patients

This group consists of participants who suffered a traumatic brain injury an average of 4 months to 4 years prior to testing. Patients must not have history of prior head injury, substance abuse, psychiatric illness, or contraindications to MRI.

Controls (no traumatic brain injury)

This group consists of participants who do not have a history of brain trauma. Furthermore, controls must not suffer from substance abuse, psychiatric illness, or have contraindications to the MRI.

Eligibility Criteria

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

Participants will be recruited through the neurosurgery clinic at San Francisco General Hospital or referred to us by colleagues.

You may qualify if:

  • years of age
  • single episode of blunt traumatic brain injury
  • symptoms of persistent post-concussive syndrome present an average of 4 months to 4 years since date of injury
  • fluency in English (cognitive battery not available in other languages)
  • capable of self-consent

You may not qualify if:

  • \< 18 years or \> 50 years of age
  • pregnancy
  • history of previous TBI with loss of consciousness
  • alcoholism as evidenced by Audit questionnaire
  • regular use of illicit drugs
  • non-English fluency
  • significant psychiatric history excluding mild depression or anxiety disorder any contraindication to MRI, including claustrophobia, pregnancy, any trauma or surgery which may have left ferromagnetic material in the body, ferromagnetic implants or pacemakers; and inability to lie still for 1 hour or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (5)

  • Arfanakis K, Haughton VM, Carew JD, Rogers BP, Dempsey RJ, Meyerand ME. Diffusion tensor MR imaging in diffuse axonal injury. AJNR Am J Neuroradiol. 2002 May;23(5):794-802.

    PMID: 12006280BACKGROUND
  • Deipolyi AR, Mukherjee P, Gill K, Henry RG, Partridge SC, Veeraraghavan S, Jin H, Lu Y, Miller SP, Ferriero DM, Vigneron DB, Barkovich AJ. Comparing microstructural and macrostructural development of the cerebral cortex in premature newborns: diffusion tensor imaging versus cortical gyration. Neuroimage. 2005 Sep;27(3):579-86. doi: 10.1016/j.neuroimage.2005.04.027.

    PMID: 15921934BACKGROUND
  • Hillebrand A, Singh KD, Holliday IE, Furlong PL, Barnes GR. A new approach to neuroimaging with magnetoencephalography. Hum Brain Mapp. 2005 Jun;25(2):199-211. doi: 10.1002/hbm.20102.

    PMID: 15846771BACKGROUND
  • Hughes DG, Jackson A, Mason DL, Berry E, Hollis S, Yates DW. Abnormalities on magnetic resonance imaging seen acutely following mild traumatic brain injury: correlation with neuropsychological tests and delayed recovery. Neuroradiology. 2004 Jul;46(7):550-8. doi: 10.1007/s00234-004-1227-x. Epub 2004 Jun 8.

    PMID: 15185054BACKGROUND
  • Huisman TA, Sorensen AG, Hergan K, Gonzalez RG, Schaefer PW. Diffusion-weighted imaging for the evaluation of diffuse axonal injury in closed head injury. J Comput Assist Tomogr. 2003 Jan-Feb;27(1):5-11. doi: 10.1097/00004728-200301000-00002.

    PMID: 12544235BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticPost-Concussion Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pratik Mukherjee, MD, PhD

    UCSF Department of Radiology and Bioengineering

    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

February 9, 2011

First Posted

February 17, 2011

Study Start

February 1, 2007

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 4, 2018

Record last verified: 2018-11

Locations