NCT05219331

Hydrocephalus Treatment on Persistent Disorder of Consciousness

Impact of Hydrocephalus Treatment on Persistent Disorder of Consciousness Following Acute Brain Injury

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorder of Consciousness

Interventions

Type	Name	Description
PROCEDURE	Ventriculoperitoneal shunt	Treatment oh hydrocephalus

Timeline

• Start date: 2022-09-16
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2022-02-02
• Last updated: 2024-02-28

Locations

2 sites across 1 country: France