Clinical trial NCT05219331: Hydrocephalus Treatment on Persistent Disorder of Consciousness
Official title: Impact of Hydrocephalus Treatment on Persistent Disorder of Consciousness Following Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disorder of Consciousness
Keywords: consciousness disorder
hydrocephalus
ventriculoperitoneal shunt
autonomic nervous system
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: After acute brain injury or haemorrhagic stroke, hydrocephalus might participate to consciousness disorder. We plan to explore whether ventriculoperitoneal shunt insertion improves consciousness in patients with vegetative or minimally conscious state and hydrocephalus. Patients with acute brain injury, persistent consciousness disorder and hydrocephalus will be shunted with a detailed follow-up at 3 months combining: clinical evaluation, FluoroDésoxyGlucose positron emission tomography imaging, high density electroencephalogram, electrocardiogram Holter and sympathetic activity by microneurography.

Detailed description: Persistent disorder of consciousness following acute brain injury is a major public health problem. Advances in intensive care allow a growing number of patients to survive after acute brain injury. However, one third of patients in coma following acute brain injury will not recover a consciousness. To date, no specific treatment has shown its effectiveness in the cognitive recovery of those patients. Few clinical cases suggest that hydrocephalus, which is the impairment of cerebrospinal fluid circulation in the brain, may participate to prolonged disorder of consciousness. Hence treating hydrocephalus with a shunt might improve disorders of consciousness. It is possible to gauge intracranial fluid circulation, that is hydrodynamics quantification, and measure resistance to cerebrospinal fluid outflow. Demonstration of an altered hydrodynamics favours the implantation of a shunt to improve cerebrospinal fluid circulation that might modulate brain region involved in the emergence of consciousness. The study hypothesis is that shunting a patient with persistent disorder of consciousness due to acute brain injury and hydrocephalus might improve his state of consciousness. The neural processes underlying will be assessed through comparative analyses of brain metabolic and electrophysiological signatures.

Eligibility criteria: Inclusion Criteria:

* adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.

Exclusion Criteria:

* pregnancy, no consent

Primary outcomes:
measure: Coma Recovery Scale-revised scale
timeFrame: 3 months and one years after shunt insertion
Secondary outcomes:
measure: 18Ffluorodeoxyglucose positron emission tomography
timeFrame: 3 months after shunt insertion
measure: High density electroencephalogram
timeFrame: 3 months after shunt insertion
measure: Holter electrocardiogram and blood pressure
timeFrame: 3 months after shunt insertion
measure: muscle sympathetic nerve activity
timeFrame: 3 months after shunt insertion
measure: catecholamines dosage
timeFrame: 3 months after shunt insertion
Other outcomes:
Locations:
city: Gaillac-Toulza
country: France
facility: Clinique de Verdaich
city: Toulouse
country: France
facility: Eric SCHMIDT
Study officials:
affiliation: University Hospital, Toulouse
name: Eric SCHMIDT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: