MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury (Dana-REAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01298557
First received: February 9, 2011
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition
Traumatic Brain Injury
Post-concussive Symptoms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging of Neural Function and Connectivity in Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Changes in white matter tract structure [ Time Frame: up to 4 years following date of injury ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Neurocognitive function [ Time Frame: up to 4 years following date of injury ] [ Designated as safety issue: No ]
    We hope to better understand the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) by correlating neurocognitive testing data with imaging data. We will also compare neurocognitive testing data between patients and controls to help illustrate the impact of brain trauma on these neurocognitive symptoms. Our participants receive testing at only one time-point.

  • Cortical activation [ Time Frame: up to 4 years following date of injury ] [ Designated as safety issue: No ]
    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 impaired cortical activation can be detected with magnetoencephalography (MEG). We will compare patients' data with data of controls. Our participants are scanned at only one time-point.


Enrollment: 69
Study Start Date: February 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 18-50 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

Exclusion Criteria:

  • < 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298557

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Pratik Mukherjee, MD, PhD UCSF Department of Radiology and Bioengineering
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01298557     History of Changes
Other Study ID Numbers: Dana-REAC
Study First Received: February 9, 2011
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Traumatic brain injury
Post-concussive symptoms
Brain imaging
Neurocognitive testing

Additional relevant MeSH terms:
Brain Injuries
Post-Concussion Syndrome
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 14, 2014