Hydrocephalus Treatment on Persistent Disorder of Consciousness

NCT ID: NCT05219331

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-16
• Study Completion Date: 2025-04-01

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.

Conditions

Disorder of Consciousness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Disorder of consciousness

Ventriculo peritoneal shunt

Group Type: OTHER

Ventriculoperitoneal shunt

Intervention Type: PROCEDURE

Treatment oh hydrocephalus

Interventions

Ventriculoperitoneal shunt

Treatment oh hydrocephalus

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy, no consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric SCHMIDT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Clinique de Verdaich

Gaillac-Toulza, , France

Site Status: RECRUITING

Eric SCHMIDT

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric SCHMIDT, MD, PhD

Role: CONTACT

schmidt.e@chu-toulouse.fr

0561775606 ext. 33

Facility Contacts

MAURUC Elsa, MD

Role: primary

PIOT Jean-Christophe

Role: backup

jc.piot@clinique-verdaich.com

Eric SCHMIDT, MD

Role: primary

schmidt.e@chu-toulouse.fr

0561775606

Other Identifiers

RC31/20/0010

Identifier Type: -

Identifier Source: org_study_id