Disorder of ConsciousnessHYCONCT05219331
Hydrocephalus Treatment on Persistent Disorder of Consciousness
A study testing Ventriculoperitoneal shunt in people with Disorder of Consciousness, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Ventriculoperitoneal shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Sep 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.
Who cannot join
- pregnancy, no consent
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Clinique de Verdaich
Gaillac-Toulza, 31550
MAURUC Elsa, MD
PIOT Jean-Christophe, jc.piot@clinique-verdaich.com
- Recruiting
Eric SCHMIDT
Toulouse, 31059
Eric SCHMIDT, MD, 0561775606, schmidt.e@chu-toulouse.fr
About this study
Official title: 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.
Read the 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
- Being tested
- Ventriculoperitoneal shunt
- Keywords
- consciousness disorder, hydrocephalus, ventriculoperitoneal shunt, autonomic nervous system
- Medical subject headings
- Consciousness Disorders, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriculoperitoneal shuntProcedure or surgery
Treatment oh hydrocephalus
| Study group | Role | What they receive |
|---|---|---|
| Disorder of consciousness | Other | Ventriculo peritoneal shunt Receives: Procedure: Ventriculoperitoneal shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-revised scale
Yield stable estimates of patient consciousness status (higher scores mean better outcome)
Measured: 3 months and one years after shunt insertion
Secondary outcomes (5)
18Ffluorodeoxyglucose positron emission tomography
18Ffluorodeoxyglucose positron emission tomography to measure brain glucose uptake across various brain region involved in consciousness
Measured: 3 months after shunt insertion
High density electroencephalogram
electroencephalogram-based automatic classification to apprehend brain connectivity and conscious states
Measured: 3 months after shunt insertion
Holter electrocardiogram and blood pressure
electrocardiogram recording and analysis and blood pressure to gauge heart rate variability
Measured: 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
Measured: 3 months after shunt insertion
catecholamines dosage
catecholamines dosage in blood
Measured: 3 months after shunt insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start16 Sep 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric SCHMIDT, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219331
- Sponsor's protocol ID
- RC31/20/0010
- Acronym
- HYCO
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hydrocephalus Treatment on Persistent Disorder of Consciousness Following Acute Brain Injury
- ClinicalTrials.gov ID
- NCT05219331
- Acronym / sponsor ID
- HYCO / RC31/20/0010
- Conditions
- Disorder of Consciousness
- Keywords
- consciousness disorder, hydrocephalus, ventriculoperitoneal shunt, autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disorder of consciousness | Other | Procedure: Ventriculoperitoneal shuntVentriculo peritoneal shunt |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.
Key exclusion criteria (1 listed)
- pregnancy, no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventriculoperitoneal shuntTreatment oh hydrocephalus | Procedure or surgery | Disorder of consciousness |
Primary outcome
Coma Recovery Scale-revised scale
Time frame: 3 months and one years after shunt insertion
Yield stable estimates of patient consciousness status (higher scores mean better outcome)
5 secondary outcomes
18Ffluorodeoxyglucose positron emission tomography
Time frame: 3 months after shunt insertion
High density electroencephalogram
Time frame: 3 months after shunt insertion
Holter electrocardiogram and blood pressure
Time frame: 3 months after shunt insertion
muscle sympathetic nerve activity
Time frame: 3 months after shunt insertion
catecholamines dosage
Time frame: 3 months after shunt insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric SCHMIDT, MD, PhD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventriculoperitoneal shunt in people with Disorder of Consciousness, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric SCHMIDT, MD, PhD (0561775606 ext. 33, schmidt.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale-revised scale (time frame: 3 months and one years after shunt insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.