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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02424656

Acronym

ABCinTBI

Enrollment

Registered

2015-04-23

Start date

2014-09-30

Completion date

2021-09-30

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury, Disorders of Consciousness

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.

Interventions

PROCEDUREMRI

EEG-functional MRI, structural MRI, diffusion MRI

PROCEDURETMS-EEG

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

PROCEDUREFDG-PET

OTHERClinical 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).

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026