NCT02424656

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Danish Research Centre for Magnetic Resonance · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Traumatic Brain Injury
• Disorders of Consciousness

Interventions

Type	Name	Description
PROCEDURE	MRI	EEG-functional MRI, structural MRI, diffusion MRI
PROCEDURE	TMS-EEG	Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
PROCEDURE	FDG-PET
OTHER	Clinical scales	Evaluation of DOC: Coma recovery scale-Revised (CRS-R) and Rancho Los Amigos Scale (RLAS). Evaluation of function: Functional Independent Measure (FIMTM), and Early Functional Assessment (EFA).

Timeline

• Start date: 2014-09-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2015-04-23
• Last updated: 2023-09-13

Locations

1 site across 1 country: Denmark