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

November 30, 2018 updated by: University of California, San Francisco

Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging of Neural Function and Connectivity in Traumatic Brain Injury

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in white matter tract structure
Time Frame: up to 4 years following date of injury
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive function
Time Frame: up to 4 years following date of injury
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.
up to 4 years following date of injury
Cortical activation
Time Frame: up to 4 years following date of injury
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.
up to 4 years following date of injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pratik Mukherjee, MD, PhD, UCSF Department of Radiology and Bioengineering

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (ESTIMATE)

February 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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