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

Not Applicable

• Conditions: Disorder of Consciousness; Hydrocephalus
• Interventions: Procedure: Cerebrospinal fluid shunt

• Registration Number: NCT05237102
• Lead Sponsor: Zhuohang Wang

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.

Study Timeline

• Study First Submitted: 2021-12-16
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-11
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-23
• Study Start: 2022-04-10
• Primary Completion: 2022-10-10
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The patients did not respond to CSF tap test	Cerebrospinal fluid shunt	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 patients did respond to CSF tap test	Cerebrospinal fluid shunt	The improvement of symptoms in these participants after the CSF tap test predicts a favorable prognosis for CSF shunt.

Primary Outcome Measures

Name	Time	Method
Changes of consciousness disorder after operation	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)

Trial Locations

Locations (1)

First Affiliated Hospital of Nanchang University; 🇨🇳 NanChang, Jiangxi, China