Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology

Hydrocephalus Clinical Trial

Official title:

Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04363658
• Other study ID #: 202001015
• Status: Recruiting
• Start date: May 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2020
• Source: Xiangya Hospital of Central South University
• Contact: Jian Wang, master
• Phone: 15575874018
• Email: 1172268798[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination.

Exclusion Criteria:

Patients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour.

Patients who are participating in drug research or other clinical trials.

Related Conditions & MeSH terms

• Hydrocephalus

Locations

Country	Name	City	State
United States	Nicolet EEG	Pleasanton	California

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of glasgow outcome scale in 6 months after shunt operation		6 months
Secondary	Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure		6 months
Secondary	Revised coma recovery scale (CRS-R) in 1 week after shunting		1 week
Secondary	Modified Ashworth Scale (MAS) in 1 week after shunting		1 week
Secondary	Revised coma recovery scale (CRS-R) in 1 month after shunting		1 month
Secondary	Modified Ashworth Scale (MAS) in 1 month after shunting		1 month