Skip to main content
Clinical Trials/NCT02424656
NCT02424656
Completed
Not Applicable

Alterations in the Brain's Connectome in Severe Traumatic Brain Injury

Danish Research Centre for Magnetic Resonance1 site in 1 country35 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Danish Research Centre for Magnetic Resonance
Enrollment
35
Locations
1
Primary Endpoint
Changes in whole brain connectivity as a measure of recovery of consciousness
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study explores the changes in whole-brain connectivity that occur during recovery from severe Traumatic Brain Injury and how these changes are related to the recovery of consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the TBI episode.

Detailed Description

Severe Traumatic Brain Injury (TBI) can result in a long-lasting altered state of consciousness. At present, the underlying neurological determinants of recovery in patients with disorders of consciousness (DOC) after a severe TBI are not well understood, and individual prognosis is very limited. Moreover, the rate of misdiagnosis between different states of altered consciousness by standard clinical scales is high, which further impacts on the clinical prognosis. In this project, multimodal neuroimaging measures will be applied and whole-brain data will be obtained from patients recovering from severe TBI in a longitudinal fashion. Patients will be examined at four time points during the sub-acute stage: immediately after admission to the neurorehabilitation unit, after ten weeks of admission, at discharge, and after one year of the TBI episode. Brain connectivity will be assessed with functional Magnetic Resonance Imaging (fMRI) combined with electroencephalography (EEG), structural MRI, diffusion MRI, high-density EEG (hdEEG) alone, and hdEEG combined with Transcranial Magnetic Stimulation (EEG-TMS), and \[18F\]-fluorodeoxyglucose positron emission tomography (FDG-PET). The overall aim of the study is to find reliable biomarkers for the recovery of consciousness based on changes in cortico-cortical and cortico-subcortical brain connectivity. In order to explore this, patients that suffered a severe TBI as well a matched healthy participants group will be included in the study.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
September 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Danish Research Centre for Magnetic Resonance
Responsible Party
Principal Investigator
Principal Investigator

Hartwig R. Siebner

Professor, Head of research

Danish Research Centre for Magnetic Resonance

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in whole brain connectivity as a measure of recovery of consciousness

Time Frame: up to 32 months

Study Sites (1)

Loading locations...

Similar Trials