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

Hydrocephalus Clinical Trial

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

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Hydrocephalus

• NCT number: NCT05237102
• Study type: Interventional
• Source: Nanchang University
• Contact: Guohui Lu, doctor
• Phone: +8615070808607
• Email: guohui-lu@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2022
• Completion date: December 10, 2022