NCT06900101

Brief Summary

During the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders. Hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral injuries. Among those instruments, numerous are often described: intra cranial pressure monitoring, brain tissue oxygen pressure monitoring, scalp electroencephalography, continuous electroencephalography and Near infrared Red Spectroscopy (NIRS). Even if the value of some of those technologies are well known, many remain part of a research domain. Here we will not only try to study the correlation between different cerebral autoregulation's index described in the scientific literature but also will we try to identify and describe EEG and cardiorespiratory changes during the first week following brain injury. The objective of this study is to investigate the pathophysiology of acute brain injury and explore potent biomarkers of multimodal monitoring during the first week following acute brain injury.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Jan 2020Dec 2030

Study Start

First participant enrolled

January 1, 2020

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

10.9 years

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between ORx and PRx

    Multimodal neuro monitoring is used from 1 to 15 days after the acute brain injury.

Study Arms (1)

Patients admitted in neurocritical care in Pierre Wertheimer hospital, following acute brain injury,

Other: Study the evolution and correlation between cerebral autoregulation index

Interventions

Objective n°1: Study the correlation between autoregulation index: The investigators will look for a correlation between several auroregulation index such as the PRx, ORx and Cox. Objective n°2: Evaluation and detection of EEG prognostic patterns: The investigators will look for quantitaive EEG changes during the early phase of acute brain injuries.

Patients admitted in neurocritical care in Pierre Wertheimer hospital, following acute brain injury,

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized in neuro critical care, in Pierre Wertheimer hospital, for acute brain injury and monitored by MOBERG® system.

You may qualify if:

  • \- Patients hospitalized in neurologic critical care in Wertheimer Hospital, Bron
  • Monitored with the CNS MOBERG® monitoring system

You may not qualify if:

  • \- Refusal to participate
  • Patients under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Pierre Wertheimer

France, Bron, 69500, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

January 1, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations