Skip to content

Hydrocephalus Treatment on Persistent Disorder of Consciousness

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05219331
Acronym
HYCO
Enrollment
20
Registered
2022-02-02
Start date
2022-09-16
Completion date
2025-04-01
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

Keywords

consciousness disorder, hydrocephalus, ventriculoperitoneal shunt, autonomic nervous system

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.

Interventions

Treatment oh hydrocephalus

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* pregnancy, no consent

Design outcomes

Primary

MeasureTime frameDescription
Coma Recovery Scale-revised scale3 months and one years after shunt insertionYield stable estimates of patient consciousness status (higher scores mean better outcome)

Secondary

MeasureTime frameDescription
18Ffluorodeoxyglucose positron emission tomography3 months after shunt insertion18Ffluorodeoxyglucose positron emission tomography to measure brain glucose uptake across various brain region involved in consciousness
High density electroencephalogram3 months after shunt insertionelectroencephalogram-based automatic classification to apprehend brain connectivity and conscious states
Holter electrocardiogram and blood pressure3 months after shunt insertionelectrocardiogram recording and analysis and blood pressure to gauge heart rate variability
muscle sympathetic nerve activity3 months after shunt insertionmuscle sympathetic nerve activity measured by microneurography to record the electrical activity of the postganglionic sympathetic nerve from peroneal nerves in the lower limb
catecholamines dosage3 months after shunt insertioncatecholamines dosage in blood

Countries

France

Contacts

Primary ContactEric SCHMIDT, MD, PhD
schmidt.e@chu-toulouse.fr0561775606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026