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

September 10, 2023 updated by: Hartwig R. Siebner, Danish Research Centre for Magnetic Resonance

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2650
        • Danish Research Centre for Magnetic Resonance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  1. 30 Patients that have suffered a close-head TBI with associated DOC and that are admitted to neurorehabilitation at the TBI unit of Glostrup Hospital.
  2. 20 Healthy participants without history of neurological disorders, age-, gender-, and socioeconomically-matched to the included patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: FDG-PET
Other Names:
  • [18F]-fluorodeoxyglucose positron emission tomography
Procedure: MRI
EEG-functional MRI, structural MRI, diffusion MRI
Other Names:
  • Magnetic Resonance Imaging
Procedure: TMS-EEG
Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
Other Names:
  • Transcranial Magnetic Stimulation-Electroencephalogram
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).
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.
Procedure: FDG-PET
Other Names:
  • [18F]-fluorodeoxyglucose positron emission tomography
Procedure: MRI
EEG-functional MRI, structural MRI, diffusion MRI
Other Names:
  • Magnetic Resonance Imaging
Procedure: TMS-EEG
Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
Other Names:
  • Transcranial Magnetic Stimulation-Electroencephalogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in whole brain connectivity as a measure of recovery of consciousness
Time Frame: up to 32 months
up to 32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Research Centre for Magnetic Resonance

Collaborators

University of Kiel
Lundbeck Foundation
Glostrup University Hospital, Copenhagen
Region Capital Denmark
University of Milan
Danish Council for Independent Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimated)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2013-186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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