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

Completed

• Conditions: Traumatic Brain Injury; Disorders of Consciousness
• Interventions: Procedure: MRI; Procedure: TMS-EEG; Procedure: FDG-PET; Other: Clinical scales

• Registration Number: NCT02424656
• Lead Sponsor: Danish Research Centre for Magnetic Resonance

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-23
• Primary Completion: 2021-09
• Study Completion: 2021-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-10
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	FDG-PET	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.
2	FDG-PET	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.
1	TMS-EEG	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.
2	TMS-EEG	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.
1	Clinical scales	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.
1	MRI	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.
2	MRI	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.

Primary Outcome Measures

Name	Time	Method
Changes in whole brain connectivity as a measure of recovery of consciousness	up to 32 months

Trial Locations

Locations (1)

Danish Research Centre for Magnetic Resonance; 🇩🇰 Copenhagen, Denmark