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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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

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Traumatic Brain Injury Disorders of Consciousness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with TBI and DOC.

Experimental measures (MRI, TMS-EEG, and clinical scales) will be performed at 4 time points: within 2 weeks of admission, 6-10 weeks after admission, at discharge, 1-year follow-up after TBI episode. FDG-PET will be performed in a subset of 25 patients at 3 time points: at admission, at discharge, and at 1-year follow-up.

MRI

Intervention Type PROCEDURE

EEG-functional MRI, structural MRI, diffusion MRI

TMS-EEG

Intervention Type PROCEDURE

Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation

FDG-PET

Intervention Type PROCEDURE

Clinical scales

Intervention Type OTHER

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).

2

Healthy patient-matched controls.

Experimental measures (MRI, TMS-EEG, and FDG-PET) will be performed at 2 time points: within patient admission, and within patient discharge.

MRI

Intervention Type PROCEDURE

EEG-functional MRI, structural MRI, diffusion MRI

TMS-EEG

Intervention Type PROCEDURE

Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation

FDG-PET

Intervention Type PROCEDURE

Interventions

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MRI

EEG-functional MRI, structural MRI, diffusion MRI

Intervention Type PROCEDURE

TMS-EEG

Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation

Intervention Type PROCEDURE

FDG-PET

Intervention Type PROCEDURE

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).

Intervention Type OTHER

Other Intervention Names

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Magnetic Resonance Imaging Transcranial Magnetic Stimulation-Electroencephalogram [18F]-fluorodeoxyglucose positron emission tomography

Eligibility Criteria

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Inclusion Criteria

\- closed-head injury

\- no prior history of neurological disorders and / or head injury

Exclusion Criteria

* high level of consciousness after coma
* ventricular shunt for hydrocephalus
* large intracerebral hemorrhages or infarctions
* structural lesions in the brain stem
* locked-in syndrome due to motor pathway lesions
* contraindications for MR
* contraindications for TMS

* contraindications for MR
* contraindications for TMS

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes