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Traumatic ComaComa3DNCT03482115

Brain Network Disruptions Related to Traumatic Coma

A study testing PET examination with radiopharmaceutical drug [18F] DPA-714, MRI examination and Blood samples in people with Traumatic Coma, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Traumatic Coma
What is being tested?
PET examination with radiopharmaceutical drug [18F] DPA-714, MRI examination and Blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteFrance
Study dates
7 Mar 2018to 7 Feb 2022
Phase
Interventional
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female / age between 18 to 75 years.
  • Coma of traumatic or anoxic aetiology (GCS < 10).
  • Early (< 1 month after TBI) and after the complete withdrawal of sedative agents.
  • Written agreement for participation (legal responsible).
  • Male or female / age between 18 to 75 years, paired with patients (gender and age).
  • Written agreement for participation

Who cannot join

  • Patients without public insurance regime.
  • Pregnancy.
  • Specific contraindication to the use of MRI (metallic material) or PET (specific allergy related to the ligand).
  • pharmacological treatments which could interfere with consciousness (left to the judgement of the investigator)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hospital

    Toulouse, 31059

Other trials in France

About this study

Official title: Whole Brain Connectivity Changes Induced by Traumatic Coma: Combined Structural, Functional and Neuroinflammatory Approaches

To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).

Read the detailed description

So far, the gold standard for neuroprognostication of severe traumatic brain injury (TBI) or anoxic encephalopathy is the bedside behavioural evaluation. Nevertheless, the predictive value of such an exclusive clinical approach has been consistently reported as limited and insufficient in this challenging clinical setting. Recent theoretical and experimental data converge towards the idea of the critical implication of long-range brain connection in consciousness access and maintain. Nevertheless, previous studies have focused on the specific analysis of some targeted connections (regions of interest), and have used exclusively a single approach in neuroimaging (structural or functional imaging), with no interest in the neuro-inflammatory and neurodegenerative mechanisms likely associated with these disconnection phenomena. So, cerebral disconnection characterization at the level of the whole brain, at different stages of pathological abolition of consciousness must be made, on an anatomical, functional and metabolic scale. This descriptive study represents a first step in the identification of relevant multimodal imaging biomarkers. This will then lead to a larger study to identify the prognostic impact of these different biomarkers obtained in the acute phase of patient management.

Conditions
Traumatic Coma
Being tested
PET examination with radiopharmaceutical drug [18F] DPA-714, MRI examination, Blood samples
Keywords
coma, traumatic brain injury, anoxic encephalopathy, brain connectome, neuroinflammation, prognosis
Medical subject headings
Coma, Post-Head Injury, Coma, Brain Injuries, Traumatic, Hypoxia, Brain, Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET examination with radiopharmaceutical drug [18F] DPA-714Radiation

    Using a Biograph 6 Truepoint device. Establishment of a venous route. It will be injected 4 MBq / kg of 18F-DPA714 by the venous route with a maximum dose of 280 MBq. The patient will be placed along the orbito-meatal line. Brain acquisition will begin 60 minutes post-injection

  • MRI examinationDiagnostic test

    MRI device Philips Achieva - 3Tesla. The acquisition of the data will include different sequences (anatomical MRI, diffusion MRI, resting fMRI) and will last a total of one hour (installation and removal of the patient in the machine included).anatomical MRI associated with FLAIR (Fluid Attenuation Inversion Recovery) and diffusion tensor (tractography).

  • Blood samplesBiological

    Characterization of the TSPO phenotype (mitochondrial translocase) for tracer affinity

Study groups in NCT03482115
Study groupRoleWhat they receive
Comatose patientExperimentalSubject with coma of traumatic or anoxic aetiology : PET examination with radiopharmaceutical drug [18F] DPA-714, MRI examination and Blood samples.
Receives: Radiation: PET examination with radiopharmaceutical drug [18F] DPA-714; Diagnostic Test: MRI examination; Biological: Blood samples
control volunteersOthersubject control : PET examination with radiopharmaceutical drug [18F] DPA-714, MRI examination and Blood samples.
Receives: Radiation: PET examination with radiopharmaceutical drug [18F] DPA-714; Diagnostic Test: MRI examination; Biological: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Matrix of the neuroimaging data in PET examination

    neuroinflammation by [18F] DPA-714 during PET imaging

    Measured: First Visit, within three days after day 0

Secondary outcomes (4)

  1. Glasgow Coma Scale (GCS)

    The Glasgow Coma Scale is divided into three components : ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).

    Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).

    It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness.

    Measured: Inclusion

  2. Coma Recovery Scale Revised (CRS-R)

    The Coma Recovery Scale Revised is divided into three components : return to consciousness (RECUP), vegetative neurological state (ENV) or minimal state of consciousness (ECM).

    This scale has been validated in French, with a value of Cronbach's Alpha estimated at 0.8.

    It is a score whose values are between 100 (normal level of consciousness) and 10 (coma). ENV and ECM have intermediate values (approximately 30 and 60, respectively).

    Measured: 3 months +/- 3 days after the primary brain insult

  3. FOUR score

    The FOUR score is a scale of 4 items and 16 points concerning qualitative behavioural assessment

    Measured: 3 months +/- 3 days after the primary brain insult

  4. analysis of imaging parameters obtained in MRI

    assessing the strength of connectivity between different regions for the whole brain, measurement of anatomical connectivity, measurement of cortical thickness. All this measure use voxel/volume unit of the brain

    Measured: First Visit, within three days after day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start7 Mar 2018
  3. Primary completion7 Nov 2021
  4. Study completion7 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03482115
Sponsor's protocol ID
RC31/16/8257
Other IDs
2017-001986-26, 2017
Acronym
Coma3D
Status last verified
May 2024
First submitted
8 Feb 2018
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laureys S, Owen AM, Schiff ND. Brain function in coma, vegetative state, and related disorders. Lancet Neurol. 2004 Sep;3(9):537-46. doi: 10.1016/S1474-4422(04)00852-X.

    PubMed 15324722

  • Schiff ND. Recovery of consciousness after brain injury: a mesocircuit hypothesis. Trends Neurosci. 2010 Jan;33(1):1-9. doi: 10.1016/j.tins.2009.11.002. Epub 2009 Dec 1.

    PubMed 19954851

  • Silva S, de Pasquale F, Vuillaume C, Riu B, Loubinoux I, Geeraerts T, Seguin T, Bounes V, Fourcade O, Demonet JF, Peran P. Disruption of posteromedial large-scale neural communication predicts recovery from coma. Neurology. 2015 Dec 8;85(23):2036-44. doi: 10.1212/WNL.0000000000002196. Epub 2015 Nov 11.

    PubMed 26561296

  • Chauveau F, Van Camp N, Dolle F, Kuhnast B, Hinnen F, Damont A, Boutin H, James M, Kassiou M, Tavitian B. Comparative evaluation of the translocator protein radioligands 11C-DPA-713, 18F-DPA-714, and 11C-PK11195 in a rat model of acute neuroinflammation. J Nucl Med. 2009 Mar;50(3):468-76. doi: 10.2967/jnumed.108.058669. Epub 2009 Feb 17.

    PubMed 19223401

  • Arlicot N, Vercouillie J, Ribeiro MJ, Tauber C, Venel Y, Baulieu JL, Maia S, Corcia P, Stabin MG, Reynolds A, Kassiou M, Guilloteau D. Initial evaluation in healthy humans of [18F]DPA-714, a potential PET biomarker for neuroinflammation. Nucl Med Biol. 2012 May;39(4):570-8. doi: 10.1016/j.nucmedbio.2011.10.012. Epub 2011 Dec 14.

    PubMed 22172392

  • Sarton B, Tauber C, Fridman E, Peran P, Riu B, Vinour H, David A, Geeraerts T, Bounes F, Minville V, Delmas C, Salabert AS, Albucher JF, Bataille B, Olivot JM, Cariou A, Naccache L, Payoux P, Schiff N, Silva S. Neuroimmune activation is associated with neurological outcome in anoxic and traumatic coma. Brain. 2024 Apr 4;147(4):1321-1330. doi: 10.1093/brain/awae045.

    PubMed 38412555

  • Mattia GM, Sarton B, Villain E, Vinour H, Ferre F, Buffieres W, Le Lann MV, Franceries X, Peran P, Silva S. Multimodal MRI-Based Whole-Brain Assessment in Patients In Anoxoischemic Coma by Using 3D Convolutional Neural Networks. Neurocrit Care. 2022 Aug;37(Suppl 2):303-312. doi: 10.1007/s12028-022-01525-z. Epub 2022 Jul 25.

    PubMed 35876960

Questions about this trial

What is this clinical trial studying?

A study testing PET examination with radiopharmaceutical drug [18F] DPA-714, MRI examination and Blood samples in people with Traumatic Coma, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. 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 31 May 2024. 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 France. 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?

Matrix of the neuroimaging data in PET examination (time frame: First Visit, within three days after day 0). 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 NCT03482115, which also lists 7 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 31 May 2024.

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