Hydrocephalus Treatment on Persistent Disorder of Consciousness
- Conditions
- Disorder of Consciousness
- Interventions
- Procedure: Ventriculoperitoneal shunt
- Registration Number
- NCT05219331
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.
- pregnancy, no consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Disorder of consciousness Ventriculoperitoneal shunt Ventriculo peritoneal shunt
- Primary Outcome Measures
Name Time Method Coma Recovery Scale-revised scale 3 months and one years after shunt insertion Yield stable estimates of patient consciousness status (higher scores mean better outcome)
- Secondary Outcome Measures
Name Time Method Holter electrocardiogram and blood pressure 3 months after shunt insertion electrocardiogram recording and analysis and blood pressure to gauge heart rate variability
catecholamines dosage 3 months after shunt insertion catecholamines dosage in blood
High density electroencephalogram 3 months after shunt insertion electroencephalogram-based automatic classification to apprehend brain connectivity and conscious states
muscle sympathetic nerve activity 3 months after shunt insertion muscle sympathetic nerve activity measured by microneurography to record the electrical activity of the postganglionic sympathetic nerve from peroneal nerves in the lower limb
18Ffluorodeoxyglucose positron emission tomography 3 months after shunt insertion 18Ffluorodeoxyglucose positron emission tomography to measure brain glucose uptake across various brain region involved in consciousness
Trial Locations
- Locations (2)
Eric SCHMIDT
🇫🇷Toulouse, France
Clinique de Verdaich
🇫🇷Gaillac-Toulza, France