Hydrocephalus Treatment on Persistent Disorder of Consciousness

Disorder of Consciousness Clinical Trial

— HYCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219331
• Other study ID #: RC31/20/0010
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: Eric SCHMIDT, MD, PhD
• Phone: 0561775606
• Email: schmidt.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy, no consent

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Hydrocephalus

Intervention

Procedure:
• Ventriculoperitoneal shunt
Treatment oh hydrocephalus

Locations

Country	Name	City	State
France	Clinique de Verdaich	Gaillac-Toulza
France	Eric SCHMIDT	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	High density electroencephalogram	electroencephalogram-based automatic classification to apprehend brain connectivity and conscious states	3 months after shunt insertion
Secondary	Holter electrocardiogram and blood pressure	electrocardiogram recording and analysis and blood pressure to gauge heart rate variability	3 months after shunt insertion
Secondary	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
Secondary	catecholamines dosage	catecholamines dosage in blood	3 months after shunt insertion