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

Traumatic Brain Injury Clinical Trial

— ABCinTBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424656
• Other study ID #: H-4-2013-186
• Status: Completed
• Start date: September 2014
• Est. completion date: September 2021

Study information

• Verified date: September 2023
• Source: Danish Research Centre for Magnetic Resonance
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Consciousness Disorders
• Disorders of Consciousness
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Procedure:
• MRI
EEG-functional MRI, structural MRI, diffusion MRI
• TMS-EEG
Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
• FDG-PET

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).

Locations

Country	Name	City	State
Denmark	Danish Research Centre for Magnetic Resonance	Copenhagen

Sponsors (7)

Lead Sponsor	Collaborator
Danish Research Centre for Magnetic Resonance	Danish Council for Independent Research, Glostrup University Hospital, Copenhagen, Lundbeck Foundation, Region Capital Denmark, University of Kiel, University of Milan

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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):5 — View Citation

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 Brai — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in whole brain connectivity as a measure of recovery of consciousness		up to 32 months