Hydrocephalus Treatment on Persistent Disorder of Consciousness

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Procedure: Ventriculoperitoneal shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt. Exclusion Criteria: pregnancy, no consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Disorder of consciousness<br>Ventriculo peritoneal shunt | Procedure: Ventriculoperitoneal shunt<br>* Treatment oh hydrocephalus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coma Recovery Scale-revised scale | Yield stable estimates of patient consciousness status (higher scores mean better outcome) | 3 months and one years after shunt insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18Ffluorodeoxyglucose positron emission tomography | 18Ffluorodeoxyglucose positron emission tomography to measure brain glucose uptake across various brain region involved in consciousness | 3 months after shunt insertion | 
| High density electroencephalogram | electroencephalogram-based automatic classification to apprehend brain connectivity and conscious states | 3 months after shunt insertion | 
| Holter electrocardiogram and blood pressure | electrocardiogram recording and analysis and blood pressure to gauge heart rate variability | 3 months after shunt insertion | 
| muscle sympathetic nerve activity | muscle sympathetic nerve activity measured by microneurography to record the electrical activity of the postganglionic sympathetic nerve from peroneal nerves in the lower limb | 3 months after shunt insertion | 
| catecholamines dosage | catecholamines dosage in blood | 3 months after shunt insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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consciousness disorder, hydrocephalus, ventriculoperitoneal shunt, autonomic nervous system