HydrocephalusNCT04363658
Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology
An observational study of Hydrocephalus, run by Xiangya Hospital of Central South University at 1 site in United States.
Trial summary
The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Hydrocephalus
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2020to 31 Dec 2022
- Phase
- Observational
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient age from 16 to 70 years
Who may be able to join
- Patients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination.
Who cannot join
- Patients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour.
- Patients who are participating in drug research or other clinical trials.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Nicolet EEG
Pleasanton, California, 94566
Jian Wang, master, 557-587-4018, 1172268798@qq.com
About this study
Official title: Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology
The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.
- Conditions
- Hydrocephalus
- Keywords
- neuroelectrophysiology, hydrocephalus, disorder of consciousness
- Medical subject headings
- Hydrocephalus, Consciousness Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of glasgow outcome scale in 6 months after shunt operation
Measured: 6 months
Secondary outcomes (5)
Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure
Measured: 6 months
Revised coma recovery scale (CRS-R) in 1 week after shunting
Measured: 1 week
Modified Ashworth Scale (MAS) in 1 week after shunting
Measured: 1 week
Revised coma recovery scale (CRS-R) in 1 month after shunting
Measured: 1 month
Modified Ashworth Scale (MAS) in 1 month after shunting
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start10 May 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363658
- Sponsor's protocol ID
- 202001015
- Status last verified
- May 2020
- First submitted
- 23 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology
- ClinicalTrials.gov ID
- NCT04363658
- Acronym / sponsor ID
- 202001015
- Conditions
- Hydrocephalus
- Keywords
- neuroelectrophysiology, hydrocephalus, disorder of consciousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Apr 2020 (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.
The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient age from 16 to 70 years
Key inclusion criteria (1 listed)
- Patients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination.
Key exclusion criteria (2 listed)
- Patients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour.
- Patients who are participating in drug research or other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score of glasgow outcome scale in 6 months after shunt operation
Time frame: 6 months
5 secondary outcomes
Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure
Time frame: 6 months
Revised coma recovery scale (CRS-R) in 1 week after shunting
Time frame: 1 week
Modified Ashworth Scale (MAS) in 1 week after shunting
Time frame: 1 week
Revised coma recovery scale (CRS-R) in 1 month after shunting
Time frame: 1 month
Modified Ashworth Scale (MAS) in 1 month after shunting
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Xiangya Hospital of Central South University at 1 site in United States.
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 2 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Jian Wang, master (15575874018, 1172268798@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of glasgow outcome scale in 6 months after shunt operation (time frame: 6 months). 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 19 May 2020.