Traumatic Brain Injury Clinical Trial
— CONSCIUSOfficial title:
Connectivity and Neural Signatures of Consciousness In Unresponsive States (CONSCIUS) - a Study of Brain Activity in Disorders of Consciousness
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years old or older - Brain injury of any kind, with impaired consciousness or suspected seizures Exclusion Criteria: - < 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…) |
Country | Name | City | State |
---|---|---|---|
Belgium | UZLeuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven | Research Foundation Flanders |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | A maximum of 4 weeks after electrode implantation. | |
Secondary | 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). | A maximum of 4 weeks after electrode implantation. | |
Secondary | 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). | During electrical stimulation trials, performed in the first 4 weeks after electrode implantation. | |
Secondary | 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. | At 6 months and 1 year follow-up. |
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