## Protocol Section
### Identification Module
**NCT ID:** NCT06426615

**Acronym:** CONSCIUS

**Brief Title:** Connectivity and Neural Signatures of Consciousness in Unresponsive States

**Official Title:** Connectivity and Neural Signatures of Consciousness In Unresponsive States (CONSCIUS) - a Study of Brain Activity in Disorders of Consciousness

#### Organization Study ID Info
**ID:** s67062
#### Organization
**Class:** OTHER
**Full Name:** Universitaire Ziekenhuizen KU Leuven
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-29
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Research Foundation Flanders

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitaire Ziekenhuizen KU Leuven

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed Description:** Individuals with severe brain injury often require extensive treatment in intensive care units (ICU) and hospitalization wards while uncertainty prevails about the recovery of consciousness and cognitive abilities. Especially in the acute phase after injury, treatment decisions have a tremendous impact on outcome, but rely on assessments of behavioral responsiveness which are known to be unreliable and subject to many confounders. Objective, quantifiable diagnostic and prognostic measures that can be deployed at the bedside during the ICU stay are lacking. Development of new metrics are hampered by our lack of a fundamental understanding of (i) thalamocortical network mechanisms underlying consciousness and (ii) brain-injury induced neural dynamics impacting both consciousness and outcome. Continuous EEG monitoring has been used to aid in this respect to (i) predict recovery of consciousness and outcome, and (ii) diagnose nonconvulsive seizures in unresponsive patients. Although promising, it lacks sensitivity, spatial resolution, and causal power. There is an urgent need for techniques allowing high-precision detection of pathological dynamics, patient stratification and prediction of a capacity for consciousness recovery in acute unresponsive patients with brain injury. Intracranial electrodes as part of multimodal monitoring in subjects with impaired consciousness and severe brain injury allow continuous bedside recordings of high spatiotemporal resolution in different network nodes and allows inducing brain perturbations, transcending correlational evidence of network analysis. This technique could increase the detection and treatment of nonconvulsive seizures contributing to brain injury and unresponsiveness and simultaneously allows to study networks supporting consciousness. This can lead to new diagnostic and prognostic biomarkers for recovery based on thalamocortical profiles of activity, reactivity (complexity) and connectivity, ultimately paving to way for the development of biomarker-driven treatments to support early recovery such as deep brain stimulation. Eventually this can contribute to clinical decision making: abstaining from aggressive treatment in patients with no potential for recovery, and more importantly, continuing treatment in subjects with a responsive brain but without clear behavioural correlate.

### Conditions Module

**Conditions:**

- Acute Brain Injury

- Traumatic Brain Injury

- Consciousness Disorders

- Seizures

**Keywords:**

- Consciousness

- Seizures

- Neural dynamics

- Intracranial recordings and stimulation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Prospective inclusion of patients implanted with intracranial electrodes.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Intracranial electrodes

**Label:** Acute brain injury

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Acute brain injury

**Description:** Placement of intracranial electrodes in the cortico-subcortical system

**Name:** Intracranial electrodes

**Other Names:**

- Depth electrodes

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

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

**Time Frame:** A maximum of 4 weeks after electrode implantation.

#### Secondary Outcomes

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

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

**Time Frame:** A maximum of 4 weeks after electrode implantation.

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

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

**Time Frame:** During electrical stimulation trials, performed in the first 4 weeks after electrode implantation.

**Description:** 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.

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

**Time Frame:** At 6 months and 1 year follow-up.

### Eligibility Module

**Eligibility Criteria:** 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...)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** steven.smeijers@uzleuven.be

**Name:** Steven Smeijers, MD

**Phone:** +32 16 34 48 00

**Role:** CONTACT

**Contact 2:**

**Email:** tom.theys@uzleuven.be

**Name:** Tom Theys, MD PhD

**Phone:** +32 16 34 48 00

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Leuven

**Contacts:**

***Contact 1:***

- **Email:** steven.smeijers@uzleuven.be

- **Name:** Steven Smeijers, MD

- **Role:** CONTACT

***Contact 2:***

- **Email:** tom.theys@uzleuven.be

- **Name:** Tom Theys, MD PhD

- **Role:** CONTACT

**Country:** Belgium

**Facility:** UZLeuven

**State:** Vlaams-Brabant

**Status:** RECRUITING

**Zip:** 3000

#### Overall Officials

**Official 1:**

**Affiliation:** Universitaire Ziekenhuizen KU Leuven

**Name:** Tom Theys, MD PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: HIGH

- As Found: Traumatic Brain Injury

- ID: M15452

- Name: Seizures

- Relevance: HIGH

- As Found: Seizures

- ID: M6468

- Name: Consciousness Disorders

- Relevance: HIGH

- As Found: Consciousness Disorders

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001930

- Term: Brain Injuries

- ID: D000070642

- Term: Brain Injuries, Traumatic

- ID: D000012640

- Term: Seizures

- ID: D000003244

- Term: Consciousness Disorders

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-31
