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Connectivity and Neural Signatures of Consciousness in Unresponsive States

ConditionsAcute Brain InjuryTraumatic Brain InjuryConsciousness DisordersSeizures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

The CONSCIUS study is a prospective, interventional study including patients with acute brain injury and impaired consciousness implanted with intracranial electrodes. The aim of the study is to investigate seizures and thalamocortical neural dynamics underlying behavioral unresponsiveness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years old or older

Brain injury of any kind, with impaired consciousness or suspected seizures

Disqualifiers

< 18 years old

Known pregnancy

Any condition that, in the judgement of the investigator, makes participation in the study unsafe or unfeasible (e.g., irreversible coagulopathy, large intracranial tumors, surgical technical problems…)

Trial design

Design model

Single group

Treatments tested in this trial

  • Intracranial electrodes

    Device

    Placement of intracranial electrodes in the cortico-subcortical system

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Acute brain injuryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of electrographic epileptiform activity (ictal and ictal-interictal continuum activity) on intracranial versus scalp electroencephalography (EEG).

The primary aim is to compare the incidence of ictal and ictal-interictal continuum epileptiform activity on intracranial versus scalp EEG.

Time frame
A maximum of 4 weeks after electrode implantation.

Secondary outcomes

1

Correlating neural activity patterns (local field potentials and complexity) with behavioral responsiveness (measured using the Coma Recovery Scale-Revised).

Correlation of profiles of neural activity and reactivity with the behavioral state using the Coma Recovery Scale-Revised (CRS-R).

Time frame
A maximum of 4 weeks after electrode implantation.
2

Acute effects of electrical stimulation on behavioral responsiveness (measured using the Coma Recovery Scale-Revised).

Effects of electrical stimulation on behavioral responsiveness will be measured using the Coma Recovery Scale Revised (CRS-R).

Time frame
During electrical stimulation trials, performed in the first 4 weeks after electrode implantation.
3

Correlation of neural activity profiles with long-term outcome (Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended)

Profiles of activity and reactivity identified during the acute stage of the disease will be correlated with long-term outcome measures mainly at 6m and 1y, using Coma Recovery Scale-Revised and Glasgow Outcome Scale-Extended.

Time frame
At 6 months and 1 year follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Research Foundation Flanders

Collaborator

Source ClinicalTrials.gov
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