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Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation

Primary Purpose

Disorder of Consciousness, Hydrocephalus

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cerebrospinal fluid shunt
Sponsored by
Zhuohang Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Disorder of Consciousness focused on measuring shunt, tap test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • First Affiliated Hospital of Nanchang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

The patients did not respond to CSF tap test

The patients did respond to CSF tap test

Arm Description

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).

The improvement of symptoms in these participants after the CSF tap test predicts a favorable prognosis for CSF shunt.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
December 16, 2021
Last Updated
February 22, 2022
Sponsor
Zhuohang Wang
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1. Study Identification

Unique Protocol Identification Number
NCT05237102
Brief Title
Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 10, 2022 (Anticipated)
Primary Completion Date
October 10, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhuohang Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness, Hydrocephalus
Keywords
shunt, tap test

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The patients did not respond to CSF tap test
Arm Type
Experimental
Arm Description
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).
Arm Title
The patients did respond to CSF tap test
Arm Type
Other
Arm Description
The improvement of symptoms in these participants after the CSF tap test predicts a favorable prognosis for CSF shunt.
Intervention Type
Procedure
Intervention Name(s)
Cerebrospinal fluid shunt
Intervention Description
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)
Primary Outcome Measure Information:
Title
Changes of consciousness disorder after operation
Description
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)
Time Frame
24 hours after surgery
Title
Changes of consciousness disorder after operation
Description
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)
Time Frame
14 days after surgery
Title
Changes of consciousness disorder after operation
Description
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)
Time Frame
1 month after surgery
Title
Changes of consciousness disorder after operation
Description
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)
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohui Lu, doctor
Phone
+8615070808607
Email
guohui-lu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuohang Wang, bachelor
Phone
+8615279896028
Email
523736776@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangrong Wang, bachelor
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Nanchang University
City
NanChang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Zhuohang
Phone
+8615279896028
Email
523736776@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
From the completion of the trial to the completion of three years.
IPD Sharing Access Criteria
NO/NA
Citations:
PubMed Identifier
32484029
Citation
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.
Results Reference
result
PubMed Identifier
32001008
Citation
Ozgode 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 Reference
result
PubMed Identifier
33455998
Citation
Nakajima 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.
Results Reference
result

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Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation

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