NCT04363658

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

May 10, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

April 23, 2020

Last Update Submit

May 17, 2020

Conditions

Hydrocephalus

Keywords

neuroelectrophysiologyhydrocephalusdisorder of consciousness

Outcome Measures

Primary Outcomes (1)

  • Score of glasgow outcome scale in 6 months after shunt operation

    6 months

Secondary Outcomes (5)

  • Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure

    6 months

  • Revised coma recovery scale (CRS-R) in 1 week after shunting

    1 week

  • Modified Ashworth Scale (MAS) in 1 week after shunting

    1 week

  • Revised coma recovery scale (CRS-R) in 1 month after shunting

    1 month

  • Modified Ashworth Scale (MAS) in 1 month after shunting

    1 month

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient age from 16 to 70 years

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nicolet EEG

Pleasanton, California, 94566, United States

RECRUITING

MeSH Terms

Conditions

HydrocephalusConsciousness Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Jian Wang, master

CONTACT

155758740181172268798@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

May 10, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

US(1)