Hydrocephalus Treatment on Persistent Disorder of Consciousness (HYCO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Procedure: Ventriculoperitoneal shunt

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric SCHMIDT, MD, PhD; Phone Number: 33 0561775606; Email: schmidt.e@chu-toulouse.fr

Study Locations

• France
  • Gaillac-Toulza, France, 31550
    • Recruiting
    • Clinique de Verdaich
    • Contact: MAURUC Elsa, MD
    • Contact: PIOT Jean-Christophe; Email: jc.piot@clinique-verdaich.com
  • Toulouse, France, 31059
    • Recruiting
    • Eric SCHMIDT
    • Contact: Eric SCHMIDT, MD; Phone Number: 0561775606; Email: schmidt.e@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy, no consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Disorder of consciousness; Ventriculo peritoneal shunt	Procedure: Ventriculoperitoneal shunt; Treatment oh hydrocephalus

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Eric SCHMIDT, MD, PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: autonomic nervous system; hydrocephalus; ventriculoperitoneal shunt; consciousness disorder
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders; Hydrocephalus
• Other Study ID Numbers: RC31/20/0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No