NCT05219331

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

September 16, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

January 20, 2022

Last Update Submit

February 27, 2024

Conditions

Disorder of Consciousness

Keywords

consciousness disorderhydrocephalusventriculoperitoneal shuntautonomic nervous system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 18Ffluorodeoxyglucose positron emission tomography

    3 months after shunt insertion

  • High density electroencephalogram

    3 months after shunt insertion

  • Holter electrocardiogram and blood pressure

    3 months after shunt insertion

  • muscle sympathetic nerve activity

    3 months after shunt insertion

  • catecholamines dosage

    3 months after shunt insertion

Study Arms (1)

Disorder of consciousness

OTHER

Ventriculo peritoneal shunt

Procedure: Ventriculoperitoneal shunt

Interventions

Ventriculoperitoneal shuntPROCEDURE

Treatment oh hydrocephalus

Disorder of consciousness

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnancy, no consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique de Verdaich

Gaillac-Toulza, 31550, France

RECRUITING

Eric SCHMIDT

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Consciousness DisordersHydrocephalus

Interventions

Ventriculoperitoneal Shunt

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid ShuntsAnastomosis, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Eric SCHMIDT, MD, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric SCHMIDT, MD, PhD

CONTACT

0561775606schmidt.e@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 2, 2022

Study Start

September 16, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)