HYCO: Hydrocephalus Treatment on Persistent Disorder of Consciousness
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Disorder of consciousness Ventriculo peritoneal shunt |
Procedure: Ventriculoperitoneal shunt
Treatment oh hydrocephalus
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- High density electroencephalogram [3 months after shunt insertion]
electroencephalogram-based automatic classification to apprehend brain connectivity and conscious states
- Holter electrocardiogram and blood pressure [3 months after shunt insertion]
electrocardiogram recording and analysis and blood pressure to gauge heart rate variability
- 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
- catecholamines dosage [3 months after shunt insertion]
catecholamines dosage in blood
Eligibility Criteria
Criteria
Inclusion Criteria:
- adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.
Exclusion Criteria:
- pregnancy, no consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Eric SCHMIDT, MD, PhD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/20/0010