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Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04363658
Collaborator
(none)
65
Enrollment
1
Location
31.7
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    65 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology
    Actual Study Start Date :
    May 10, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Score of glasgow outcome scale in 6 months after shunt operation [6 months]

    Secondary Outcome Measures

    1. Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure [6 months]

    2. Revised coma recovery scale (CRS-R) in 1 week after shunting [1 week]

    3. Modified Ashworth Scale (MAS) in 1 week after shunting [1 week]

    4. Revised coma recovery scale (CRS-R) in 1 month after shunting [1 month]

    5. Modified Ashworth Scale (MAS) in 1 month after shunting [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nicolet EEG Pleasanton California United States 94566

    Sponsors and Collaborators

    • Xiangya Hospital of Central South University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiangya Hospital of Central South University
    ClinicalTrials.gov Identifier:
    NCT04363658
    Other Study ID Numbers:
    • 202001015
    First Posted:
    Apr 27, 2020
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiangya Hospital of Central South University
    neuroelectrophysiology
    hydrocephalus
    disorder of consciousness
    Additional relevant MeSH terms:
    Hydrocephalus

    Study Results

    No Results Posted as of May 19, 2020