Hydrocephalus Treatment on Persistent Disorder of Consciousness (HYCO)
Primary Purpose
Disorder of Consciousness
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ventriculoperitoneal shunt
Sponsored by
About this trial
This is an interventional basic science trial for Disorder of Consciousness focused on measuring consciousness disorder, hydrocephalus, ventriculoperitoneal shunt, autonomic nervous system
Eligibility Criteria
Inclusion Criteria:
- adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.
Exclusion Criteria:
- pregnancy, no consent
Sites / Locations
- Eric SCHMIDTRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Disorder of consciousness
Arm Description
Ventriculo peritoneal shunt
Outcomes
Primary Outcome Measures
Coma Recovery Scale-revised scale
Yield stable estimates of patient consciousness status (higher scores mean better outcome)
Secondary Outcome Measures
18Ffluorodeoxyglucose positron emission tomography
18Ffluorodeoxyglucose positron emission tomography to measure brain glucose uptake across various brain region involved in consciousness
High density electroencephalogram
electroencephalogram-based automatic classification to apprehend brain connectivity and conscious states
Holter electrocardiogram and blood pressure
electrocardiogram recording and analysis and blood pressure to gauge heart rate variability
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
catecholamines dosage
catecholamines dosage in blood
Full Information
NCT ID
NCT05219331
First Posted
January 20, 2022
Last Updated
September 20, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT05219331
Brief Title
Hydrocephalus Treatment on Persistent Disorder of Consciousness
Acronym
HYCO
Official Title
Impact of Hydrocephalus Treatment on Persistent Disorder of Consciousness Following Acute Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
Keywords
consciousness disorder, hydrocephalus, ventriculoperitoneal shunt, autonomic nervous system
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Disorder of consciousness
Arm Type
Other
Arm Description
Ventriculo peritoneal shunt
Intervention Type
Procedure
Intervention Name(s)
Ventriculoperitoneal shunt
Intervention Description
Treatment oh hydrocephalus
Primary Outcome Measure Information:
Title
Coma Recovery Scale-revised scale
Description
Yield stable estimates of patient consciousness status (higher scores mean better outcome)
Time Frame
3 months and one years after shunt insertion
Secondary Outcome Measure Information:
Title
18Ffluorodeoxyglucose positron emission tomography
Description
18Ffluorodeoxyglucose positron emission tomography to measure brain glucose uptake across various brain region involved in consciousness
Time Frame
3 months after shunt insertion
Title
High density electroencephalogram
Description
electroencephalogram-based automatic classification to apprehend brain connectivity and conscious states
Time Frame
3 months after shunt insertion
Title
Holter electrocardiogram and blood pressure
Description
electrocardiogram recording and analysis and blood pressure to gauge heart rate variability
Time Frame
3 months after shunt insertion
Title
muscle sympathetic nerve activity
Description
muscle sympathetic nerve activity measured by microneurography to record the electrical activity of the postganglionic sympathetic nerve from peroneal nerves in the lower limb
Time Frame
3 months after shunt insertion
Title
catecholamines dosage
Description
catecholamines dosage in blood
Time Frame
3 months after shunt insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.
Exclusion Criteria:
pregnancy, no consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric SCHMIDT, MD, PhD
Phone
0561775606
Ext
33
Email
schmidt.e@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric SCHMIDT, MD, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eric SCHMIDT
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric SCHMIDT, MD
Phone
0561775606
Email
schmidt.e@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Hydrocephalus Treatment on Persistent Disorder of Consciousness
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