- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424656
Alterations in the Brain's Connectome After Severe Traumatic Brain Injury (ABCinTBI)
Alterations in the Brain's Connectome in Severe Traumatic Brain Injury
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2650
- Danish Research Centre for Magnetic Resonance
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- 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.
- 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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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. |
Other Names:
EEG-functional MRI, structural MRI, diffusion MRI
Other Names:
Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
Other Names:
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).
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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. |
Other Names:
EEG-functional MRI, structural MRI, diffusion MRI
Other Names:
Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Changes in whole brain connectivity as a measure of recovery of consciousness
Time Frame: up to 32 months
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up to 32 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Conde V, Andreasen SH, Petersen TH, Larsen KB, Madsen K, Andersen KW, Akopian I, Madsen KH, Hansen CP, Poulsen I, Kammersgaard LP, Siebner HR. Alterations in the brain's connectome during recovery from severe traumatic brain injury: protocol for a longitudinal prospective study. BMJ Open. 2017 Jun 14;7(6):e016286. doi: 10.1136/bmjopen-2017-016286.
- Andreasen SH, Andersen KW, Conde V, Dyrby TB, Puonti O, Kammersgaard LP, Madsen CG, Madsen KH, Poulsen I, Siebner HR. Limited Colocalization of Microbleeds and Microstructural Changes after Severe Traumatic Brain Injury. J Neurotrauma. 2020 Feb 15;37(4):581-592. doi: 10.1089/neu.2019.6608. Epub 2019 Nov 20.
- Andreasen SH, Andersen KW, Conde V, Dyrby TB, Puonti O, Kammersgaard LP, Madsen CG, Madsen KH, Poulsen I, Siebner HR. Two Coarse Spatial Patterns of Altered Brain Microstructure Predict Post-traumatic Amnesia in the Subacute Stage of Severe Traumatic Brain Injury. Front Neurol. 2020 Sep 4;11:800. doi: 10.3389/fneur.2020.00800. eCollection 2020.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Consciousness Disorders
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
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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