Clinical trial NCT05237102: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder of Consciousness
Hydrocephalus
Keywords: shunt
tap test
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Changes of consciousness disorder after operation
timeFrame: 24 hours after surgery
measure: Changes of consciousness disorder after operation
timeFrame: 14 days after surgery
measure: Changes of consciousness disorder after operation
timeFrame: 1 month after surgery
measure: Changes of consciousness disorder after operation
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: NanChang
country: China
facility: First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: Xiangrong Wang, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.