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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrospinal fluid shunt | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guohui Lu, doctor | Contact | +8615070808607 | guohui-lu@163.com | |
| Zhuohang Wang, bachelor | Contact | +8615279896028 | 523736776@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangrong Wang, bachelor | The First Affiliated Hospital of Nanchang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32484029 | Result | 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. | |
| 32001008 | Result | 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. |
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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.
From the completion of the trial to the completion of three years.
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002557 | Cerebrospinal Fluid Shunts |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
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| 33455998 | Result | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |