Traumatic Brain InjuryABCinTBINCT02424656
Alterations in the Brain's Connectome After Severe Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Disorders of Consciousness, run by Danish Research Centre for Magnetic Resonance at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Disorders of Consciousness
- What is being tested?
- MRI, TMS-EEG and FDG-PET
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Disorders of Consciousness
- Being tested
- MRI, TMS-EEG, FDG-PET, Clinical scales
- Medical subject headings
- Brain Injuries, Traumatic, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Also called Magnetic Resonance Imaging
EEG-functional MRI, structural MRI, diffusion MRI
TMS-EEGProcedure or surgery
Also called Transcranial Magnetic Stimulation-Electroencephalogram
Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
FDG-PETProcedure or surgery
Also called [18F]-fluorodeoxyglucose positron emission tomography
Clinical scalesOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: MRI; Procedure: TMS-EEG; Procedure: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in whole brain connectivity as a measure of recovery of consciousness
Measured: up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Research Centre for Magnetic Resonance
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, University of Kiel, Glostrup University Hospital, Copenhagen, Lundbeck Foundation, Danish Council for Independent Research, Region Capital Denmark
- Responsible party
- Principal investigator, Hartwig R. Siebner, Danish Research Centre for Magnetic Resonance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424656
- Sponsor's protocol ID
- H-4-2013-186
- Acronym
- ABCinTBI
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2015
- Last updated
- 13 Sep 2023
- Results posted
- No
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.
PubMed 28615277Andreasen 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.
PubMed 31588844Andreasen 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.
PubMed 33013616
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in the Brain's Connectome in Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02424656
- Acronym / sponsor ID
- ABCinTBI / H-4-2013-186
- Conditions
- Traumatic Brain Injury, Disorders of Consciousness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Danish Research Centre for Magnetic ResonanceUniversity, hospital or other
- Collaborators
- University of Milan, University of Kiel, Glostrup University Hospital, Copenhagen, Lundbeck Foundation, Danish Council for Independent Research, Region Capital Denmark
- Study start
- Sep 2014
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: MRI, Procedure: TMS-EEG, Procedure: FDG-PET, Other: Clinical scalesPatients 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. |
| 2 | – | Procedure: MRI, Procedure: TMS-EEG, Procedure: FDG-PETHealthy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Magnetic Resonance ImagingEEG-functional MRI, structural MRI, diffusion MRI | Procedure or surgery | 1, 2 |
| TMS-EEGAlso: Transcranial Magnetic Stimulation-ElectroencephalogramSingle pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation | Procedure or surgery | 1, 2 |
| FDG-PETAlso: [18F]-fluorodeoxyglucose positron emission tomography | Procedure or surgery | 1, 2 |
| Clinical scalesEvaluation 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). | Other | 1 |
Primary outcome
Changes in whole brain connectivity as a measure of recovery of consciousness
Time frame: up to 32 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 28615277Conde 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.
- Results publication: PubMed 31588844Andreasen 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.
- Results publication: PubMed 33013616Andreasen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Disorders of Consciousness, run by Danish Research Centre for Magnetic Resonance at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in whole brain connectivity as a measure of recovery of consciousness (time frame: up to 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424656, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.