Disorder of ConsciousnessNCT05237102
Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation
A study testing Cerebrospinal fluid shunt in people with Disorder of Consciousness and Hydrocephalus, run by Zhuohang Wang at 1 site in China.
Trial summary
Patients with hydrocephalus are usually treated with cerebrospinal fluid (CFS) shunt to deal with excess cerebrospinal fluid in the brain. However, it is difficult to distinguish whether ventricular enlargement is due to hydrocephalus or other causes, such as brain injury and compensatory brain atrophy after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness, Hydrocephalus
- What is being tested?
- Cerebrospinal fluid shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 10 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, gender is not limited.
- Patients with traffic hydrocephalus caused by various reasons, including atmospheric hydrocephalus, who need cerebrospinal fluid shunt and meet the surgical indications to a certain extent.
- Typical imaging manifestations of hydrocephalus patients.
- Clinical manifestations of consciousness disorder.
- Whether or not you can participate in the study will be decided after a doctor's examination.
Who cannot join
- patients with mental or motor disorders, such as Alzheimer's disease, schizophrenia, and Parkinson's disease.
- Patients with abnormal coagulation mechanism or receiving treatment with thrombolysis agent, anticoagulant or platelet coagulant inhibitor and hemophilia.
- Patients with serious diseases of other systems, such as serious diseases of blood system, respiratory system, digestive system, urinary system and immune system, as well as patients with mental disorders and recent history of intracranial infection.
- Patients with a known disease causing ventricle enlargement.
- Female patients in pregnancy and lactation.
- Other circumstances in which the doctor judges that he cannot participate in the test.
- The subject himself or his legal representative refuses to participate in the clinical trial. Whether you are suitable to participate in this study needs the final decision after doctor's examination.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Wang Zhuohang, +8615279896028, 523736776@qq.com
About this study
Official title: Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation: Based on Patient Preoperative Imaging, EEG and Lumbar Tap Test
Patients with hydrocephalus are usually treated with cerebrospinal fluid (CFS) shunt to deal with excess cerebrospinal fluid in the brain. However, it is difficult to distinguish whether ventricular enlargement is due to hydrocephalus or other causes, such as brain injury and compensatory brain atrophy after surgery. Therefore, it is important to predict whether shunting will help patients. For this reason, clinicians must be cautious when treating patients with shunt therapy. Important assessments of the level of consciousness and continuous lumbar tap test are currently clinically common predictors before making decisions about CFS shunt therapy. However, for patients with serious disturbance of consciousness, it is difficult to predict the prognosis of surgery by observing the improvement of symptoms after lumbar tap test, which brings difficulties to the majority of clinical workers, and also easy to bring serious psychological and economic burden to patients.
In clinical practice, clinicians still lack a stable and objective method to predict postoperative outcomes for these patients.
In this clinical study, when participants performed the cerebrospinal fluid tap test to evaluate whether or not cerebrospinal fluid shunt was performed, various predictors that may be associated with CSF shunt outcomes before and after cerebrospinal fluid tap test were collected, including imaging data, EEG characteristics and changes in cerebrospinal fluid pressure. In addition, the researchers will collect the improvement of consciousness disturbance in patients with hydrocephalus before and after cerebrospinal fluid shunt, in order to explore the correlation between preoperative imaging data, EEG characteristics, the results of cerebrospinal fluid tap test and the improvement of consciousness disorders. A scheme of consciousness assessment based on the results of imaging, EEG and tap test results afte CSF tap test was proposed.
Read the detailed description
Among them, imaging parameters include:
Evans index, EI; Callosal angle, CA; Z-Evans index, Z-EI; Brain/ventricle ratio, BVR; Frontal horn ratio, FHR; Frontal and occipital horn ratio, FOR/FOHR; Frontal and Temporal Horn Ratio, FTHR; Bicaudate ratio，BCR; Cella media ratio, CMR, etc. and the disorder of consciousness scales include: Coma recovery scale-Revised，CRS-R Glasgow-Pittsburgh cerebral performance categories Glasgow coma scale, GCS, etc.
- Conditions
- Disorder of Consciousness, Hydrocephalus
- Being tested
- Cerebrospinal fluid shunt
- Keywords
- shunt, tap test
- 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.
Cerebrospinal fluid shuntProcedure or surgery
The procedure is designed to reduce the amount of cerebrospinal fluid in a patient's brain by draining it through a shunt tube:
①V-P shunt is suitable for most types of hydrocephalus; ②L-P shunt is suitable for traffic hydrocephalus and positive pressure hydrocephalus, and patients with lower cerebellar tonsil hernia are contraindications; ③ Common terms of ventriculoatrial (V-A) shunt are not suitable for V-P shunt (abdominal infection, serious respiratory and circulatory diseases are contraindications); ④ The third ventriculostomy is suitable for patients with non-traffic and partial traffic hydrocephalus （infants and patients with severe ventricular enlargement should be cautious, and patients with shunt tube cannot be placed due to ventricular conditions）; ⑤Other shunt methods include septum pellucidum fistula and Torshunt （ventriculo-occipital cistern shunt after tumor resection）
| Study group | Role | What they receive |
|---|---|---|
| The patients did not respond to CSF tap test | Experimental | Participants assigned to the experimental group did not respond to the CSF tap test and did not show improvement in general symptoms of hydrocephalus and disturbance of consciousness, but there may be changes in eeg and imaging parameters (it is unknown whether such changes are related to surgical outcome). Receives: Procedure: Cerebrospinal fluid shunt |
| The patients did respond to CSF tap test | Other | The improvement of symptoms in these participants after the CSF tap test predicts a favorable prognosis for CSF shunt. Receives: Procedure: Cerebrospinal fluid shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of consciousness disorder after operation
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Measured: 24 hours after surgery
Changes of consciousness disorder after operation
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Measured: 14 days after surgery
Changes of consciousness disorder after operation
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Measured: 1 month after surgery
Changes of consciousness disorder after operation
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start10 Apr 2022 (estimated)
- Primary completion10 Oct 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuohang Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuohang Wang, Nanchang University
- Investigators
- Xiangrong Wang, bachelor, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237102
- Sponsor's protocol ID
- NanchangUZWang
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical trial had a separate Case Report Form customized for each participant, including the basic situation, state of the illness and prognosis of the patient. And the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code are to be shared with other researchers too.
Publications
Arnts H, van Erp WS, Sanz LRD, Lavrijsen JCM, Schuurman R, Laureys S, Vandertop WP, van den Munckhof P. The Dilemma of Hydrocephalus in Prolonged Disorders of Consciousness. J Neurotrauma. 2020 Oct 15;37(20):2150-2156. doi: 10.1089/neu.2020.7129. Epub 2020 Jul 22.
PubMed 32484029Ozgode Yigin B, Algin O, Saygili G. Comparison of morphometric parameters in prediction of hydrocephalus using random forests. Comput Biol Med. 2020 Jan;116:103547. doi: 10.1016/j.compbiomed.2019.103547. Epub 2019 Nov 20.
PubMed 32001008Nakajima M, Yamada S, Miyajima M, Ishii K, Kuriyama N, Kazui H, Kanemoto H, Suehiro T, Yoshiyama K, Kameda M, Kajimoto Y, Mase M, Murai H, Kita D, Kimura T, Samejima N, Tokuda T, Kaijima M, Akiba C, Kawamura K, Atsuchi M, Hirata Y, Matsumae M, Sasaki M, Yamashita F, Aoki S, Irie R, Miyake H, Kato T, Mori E, Ishikawa M, Date I, Arai H; research committee of idiopathic normal pressure hydrocephalus. Guidelines for Management of Idiopathic Normal Pressure Hydrocephalus (Third Edition): Endorsed by the Japanese Society of Normal Pressure Hydrocephalus. Neurol Med Chir (Tokyo). 2021 Feb 15;61(2):63-97. doi: 10.2176/nmc.st.2020-0292. Epub 2021 Jan 15.
PubMed 33455998
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation: Based on Patient Preoperative Imaging, EEG and Lumbar Tap Test
- ClinicalTrials.gov ID
- NCT05237102
- Acronym / sponsor ID
- NanchangUZWang
- Conditions
- Disorder of Consciousness, Hydrocephalus
- Keywords
- shunt, tap test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhuohang WangUniversity, hospital or other
- Study start
- 10 Apr 2022 (estimated)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 11 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.
Patients with hydrocephalus are usually treated with cerebrospinal fluid (CFS) shunt to deal with excess cerebrospinal fluid in the brain. However, it is difficult to distinguish whether ventricular enlargement is due to hydrocephalus or other causes, such as brain injury and compensatory brain atrophy after surgery. Therefore, it is important to predict whether shunting will help patients. For this reason, clinicians must be cautious when treating patients with shunt therapy. Important assessments of the level of consciousness and continuous lumbar tap test are currently clinically common predictors before making decisions about CFS shunt therapy. However, for patients with serious disturbance of consciousness, it is difficult to predict the prognosis of surgery by observing the improvement of symptoms after lumbar tap test, which brings difficulties to the majority of clinical workers, and also easy to bring serious psychological and economic burden to patients.
In clinical practice, clinicians still lack a stable and objective method to predict postoperative outcomes for these patients.
In this clinical study, when participants performed the cerebrospinal fluid tap test to evaluate whether or not cerebrospinal fluid shunt was performed, various predictors that may be associated with CSF shunt outcomes before and after cerebrospinal fluid tap test were collected, including imaging data, EEG characteristics and changes in cerebrospinal fluid pressure. In addition, the researchers will collect the improvement of consciousness disturbance in patients with hydrocephalus before and after cerebrospinal fluid shunt, in order to explore the correlation between preoperative imaging data, EEG characteristics, the results of cerebrospinal fluid tap test and the improvement of consciousness disorders. A scheme of consciousness assessment based on the results of imaging, EEG and tap test results afte CSF tap test was proposed.
Detailed description
Among them, imaging parameters include:
Evans index, EI; Callosal angle, CA; Z-Evans index, Z-EI; Brain/ventricle ratio, BVR; Frontal horn ratio, FHR; Frontal and occipital horn ratio, FOR/FOHR; Frontal and Temporal Horn Ratio, FTHR; Bicaudate ratio，BCR; Cella media ratio, CMR, etc. and the disorder of consciousness scales include: Coma recovery scale-Revised，CRS-R Glasgow-Pittsburgh cerebral performance categories Glasgow coma scale, GCS, etc.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The patients did not respond to CSF tap test | Experimental | Procedure: Cerebrospinal fluid shuntParticipants assigned to the experimental group did not respond to the CSF tap test and did not show improvement in general symptoms of hydrocephalus and disturbance of consciousness, but there may be changes in eeg and imaging parameters (it is unknown whether such changes are related to surgical outcome). |
| The patients did respond to CSF tap test | Other | Procedure: Cerebrospinal fluid shuntThe improvement of symptoms in these participants after the CSF tap test predicts a favorable prognosis for CSF shunt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18, gender is not limited.
- Patients with traffic hydrocephalus caused by various reasons, including atmospheric hydrocephalus, who need cerebrospinal fluid shunt and meet the surgical indications to a certain extent.
- Typical imaging manifestations of hydrocephalus patients.
- Clinical manifestations of consciousness disorder.
- Whether or not you can participate in the study will be decided after a doctor's examination.
Key exclusion criteria (7 listed)
- patients with mental or motor disorders, such as Alzheimer's disease, schizophrenia, and Parkinson's disease.
- Patients with abnormal coagulation mechanism or receiving treatment with thrombolysis agent, anticoagulant or platelet coagulant inhibitor and hemophilia.
- Patients with serious diseases of other systems, such as serious diseases of blood system, respiratory system, digestive system, urinary system and immune system, as well as patients with mental disorders and recent history of intracranial infection.
- Patients with a known disease causing ventricle enlargement.
- Female patients in pregnancy and lactation.
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 |
|---|---|---|
| Cerebrospinal fluid shuntThe procedure is designed to reduce the amount of cerebrospinal fluid in a patient's brain by draining it through a shunt tube: ①V-P shunt is suitable for most types of hydrocephalus; ②L-P shunt is suitable for traffic hydrocephalus and positive pressure hydrocephalus, and patients with lower cerebellar tonsil hernia are contraindications; ③ Common terms of ventriculoatrial (V-A) shunt are not suitable for V-P shunt (abdominal infection, serious respiratory and circulatory diseases are contraindications); ④ The third ventriculostomy is suitable for patients with non-traffic and partial traffic hydrocephalus （infants and patients with severe ventricular enlargement should be cautious, and patients with shunt tube cannot be placed due to ventricular conditions）; ⑤Other shunt methods include septum pellucidum fistula and Torshunt （ventriculo-occipital cistern shunt after tumor resection） | Procedure or surgery | The patients did not respond to CSF tap test, The patients did respond to CSF tap test |
Primary outcome
Changes of consciousness disorder after operation
Time frame: 24 hours after surgery
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Changes of consciousness disorder after operation
Time frame: 14 days after surgery
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Changes of consciousness disorder after operation
Time frame: 1 month after surgery
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Changes of consciousness disorder after operation
Time frame: 6 months after surgery
The score of the scale Coma recovery scale-Revised will be used to assess changes in consciousness before and after surgery (the highest score is 23 points and the lowest score is 0 points. A higher score indicates a better prognosis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Results publication: PubMed 32484029Arnts H, van Erp WS, Sanz LRD, Lavrijsen JCM, Schuurman R, Laureys S, Vandertop WP, van den Munckhof P. The Dilemma of Hydrocephalus in Prolonged Disorders of Consciousness. J Neurotrauma. 2020 Oct 15;37(20):2150-2156. doi: 10.1089/neu.2020.7129. Epub 2020 Jul 22.
- Results publication: PubMed 32001008Ozgode Yigin B, Algin O, Saygili G. Comparison of morphometric parameters in prediction of hydrocephalus using random forests. Comput Biol Med. 2020 Jan;116:103547. doi: 10.1016/j.compbiomed.2019.103547. Epub 2019 Nov 20.
- Results publication: PubMed 33455998Nakajima M, Yamada S, Miyajima M, Ishii K, Kuriyama N, Kazui H, Kanemoto H, Suehiro T, Yoshiyama K, Kameda M, Kajimoto Y, Mase M, Murai H, Kita D, Kimura T, Samejima N, Tokuda T, Kaijima M, Akiba C, Kawamura K, Atsuchi M, Hirata Y, Matsumae M, Sasaki M, Yamashita F, Aoki S, Irie R, Miyake H, Kato T, Mori E, Ishikawa M, Date I, Arai H; research committee of idiopathic normal pressure hydrocephalus. Guidelines for Management of Idiopathic Normal Pressure Hydrocephalus (Third Edition): Endorsed by the Japanese Society of Normal Pressure Hydrocephalus. Neurol Med Chir (Tokyo). 2021 Feb 15;61(2):63-97. doi: 10.2176/nmc.st.2020-0292. Epub 2021 Jan 15.
- Individual participant dataSharing planned: Yes. The clinical trial had a separate Case Report Form customized for each participant, including the basic situation, state of the illness and prognosis of the patient. And the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code are to be shared with other researchers too.
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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.
Xiangrong Wang, bachelor principal investigator
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebrospinal fluid shunt in people with Disorder of Consciousness and Hydrocephalus, run by Zhuohang Wang at 1 site in China.
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 5 inclusion and 7 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 23 Feb 2022. 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 China. 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 Guohui Lu, doctor (+8615070808607, guohui-lu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of consciousness disorder after operation (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237102, which also lists 3 linked publications.
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 23 Feb 2022.