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

NCT02424656 | Completed

• 1 other identifier: H-4-2013-186
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Disorders of Consciousness

Outcome Measures

Primary Outcomes (1)

• Changes in whole brain connectivity as a measure of recovery of consciousness

  up to 32 months

Study Arms (2)

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: MRI; Procedure: TMS-EEG; Procedure: FDG-PET; Other: Clinical scales

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: MRI; Procedure: TMS-EEG; Procedure: FDG-PET

Interventions

MRI PROCEDURE

EEG-functional MRI, structural MRI, diffusion MRI

Also known as: Magnetic Resonance Imaging

1; 2

TMS-EEG PROCEDURE

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

Also known as: Transcranial Magnetic Stimulation-Electroencephalogram

1; 2

FDG-PET PROCEDURE

Also known as: [18F]-fluorodeoxyglucose positron emission tomography

1; 2

Clinical scales OTHER

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).

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- closed-head injury

You may not qualify if:

• 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
• \- no prior history of neurological disorders and / or head injury
• contraindications for MR
• contraindications for TMS

Sponsors & Collaborators

• Danish Research Centre for Magnetic Resonance: lead
• University of Milan: collaborator
• University of Kiel: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Lundbeck Foundation: collaborator
• Danish Council for Independent Research: collaborator
• Region Capital Denmark: collaborator

Study Sites (1)

Danish Research Centre for Magnetic Resonance

Copenhagen, 2650, Denmark

Location

Related Publications (3)

• 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.

  PMID: 28615277 BACKGROUND

• 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.

  PMID: 31588844 RESULT

• 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.

  PMID: 33013616 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Consciousness Disorders

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of research

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 23, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

DK (1)