Alterations in the Brain's Connectome After Severe Traumatic Brain Injury (ABCinTBI)

Danish Research Centre for Magnetic Resonance

Status: Completed

Conditions: Traumatic Brain Injury; Disorders of Consciousness

Treatments: Procedure: FDG-PET; Procedure: TMS-EEG; Procedure: MRI; Other: Clinical scales

Study type: Observational

Funder types: Other

Identifiers

NCT02424656

H-4-2013-186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient's inclusion criteria:

• closed-head injury

Patient's 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

Healthy participant's inclusion criteria:

• no prior history of neurological disorders and / or head injury

Healthy participant's exclusion criteria:

• contraindications for MR
• contraindications for TMS

Trial design

35 participants in 2 patient groups

1

Description:

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.

Treatment:

Procedure: MRI

Other: Clinical scales

Procedure: TMS-EEG

Procedure: FDG-PET

2

Description:

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.

Treatment:

Procedure: MRI

Procedure: TMS-EEG

Procedure: FDG-PET