Connectivity and Neural Signatures of Consciousness in Unresponsive States

NCT06426615 | Recruiting DMC

• 1 other identifier: s67062
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Brain Injury; Traumatic Brain Injury; Consciousness Disorders; Seizures

Keywords

Consciousness; Seizures; Neural dynamics; Intracranial recordings and stimulation

Outcome Measures

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.

  A maximum of 4 weeks after electrode implantation.

Secondary Outcomes (3)

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

  A maximum of 4 weeks after electrode implantation.

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

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

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

  At 6 months and 1 year follow-up.

Study Arms (1)

Acute brain injury

EXPERIMENTAL

Patients with acute brain injury with reduced consciousness that undergo multimodal intracranial monitoring, or with suspected seizures

Device: Intracranial electrodes

Interventions

Intracranial electrodes DEVICE

Placement of intracranial electrodes in the cortico-subcortical system

Also known as: Depth electrodes

Acute brain injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Brain injury of any kind, with impaired consciousness or suspected seizures

You may not qualify if:

• \< 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…)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Consciousness Disorders; Seizures

Condition Hierarchy (Ancestors)

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

Study Officials

• Tom Theys, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Smeijers, MD

CONTACT

+32 16 34 48 00; steven.smeijers@uzleuven.be

Tom Theys, MD PhD

CONTACT

+32 16 34 48 00; tom.theys@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective inclusion of patients implanted with intracranial electrodes.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: May 23, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-03

Locations

BE (1)