Back to resultsA Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness
Primary Purpose
Disorder of Consciousness
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zolpidem Tartrate Tablets
Sponsored by
About this trial
This is an interventional screening trial for Disorder of Consciousness focused on measuring Prolonged disorders of consciousness, Zolpidem, EEG, Prognosis, Unresponsive wakefulness syndrome, Minimally conscious state
Eligibility Criteria
Inclusion Criteria:
- presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;
- time since onset > 4 weeks;
- no history of neurodegenerative or psychiatric diseases.
Exclusion Criteria:
- allergic to zolpidem;
- currently receiving zolpidem or related benzodiazepines;
- diagnosed with seizure or status epilepticus.
Sites / Locations
- Department of Neurology, Xijing Hospital, Fourth Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with prolonged disorders of consciousness
Healthy volunteers
Arm Description
age ≥ 18 years; presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission; time since onset > 4 weeks; no history of neurodegenerative or psychiatric diseases. All patients were administered 10 mg of zolpidem tartrate tablets via a feeding tube and received EEG-reactivity test.
Healthy volunteers without any history of autonomic or any other nervous system disorder were included in this study. They were administered 10 mg of zolpidem tartrate tablets orally.
Outcomes
Primary Outcome Measures
The Coma Recovery Scale-Revised
The consciousness was independently assessed using CRS-R six months after enrollment by a trained neurologist blinded to the clinical data. Patients who transitioned from UWS to MCS (UWS-MCS) or to emergence from MCS (EMCS) (UWS-EMCS), from MCS minus to MCS plus (MCS--MCS+) or to EMCS (MCS--EMCS), and from MCS to EMCS (MCS-EMCS) were categorized in the improved consciousness group. The unimproved consciousness was defined as a reduced or unchanged level of consciousness at six months.
Secondary Outcome Measures
Full Information
NCT ID
NCT02948660
First Posted
October 23, 2016
Last Updated
May 24, 2022
Sponsor
Xijing Hospital
Collaborators
Guangzhou University of Chinese Medicine, University of Melbourne, Tianjin University
1. Study Identification
Unique Protocol Identification Number
NCT02948660
Brief Title
A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness
Official Title
EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Guangzhou University of Chinese Medicine, University of Melbourne, Tianjin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The research contains two parts. Part 1: To explore whether EEG responses to zolpidem can assess consciousness circuit integrity and predict the evolution of consciousness in patients with prolonged disorders of consciousness; Part 2: To explore if quantitative EEG reactivity might predict the prognosis of disorders of consciousness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
Keywords
Prolonged disorders of consciousness, Zolpidem, EEG, Prognosis, Unresponsive wakefulness syndrome, Minimally conscious state
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with prolonged disorders of consciousness
Arm Type
Experimental
Arm Description
age ≥ 18 years;
presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;
time since onset > 4 weeks;
no history of neurodegenerative or psychiatric diseases.
All patients were administered 10 mg of zolpidem tartrate tablets via a feeding tube and received EEG-reactivity test.
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Healthy volunteers without any history of autonomic or any other nervous system disorder were included in this study. They were administered 10 mg of zolpidem tartrate tablets orally.
Intervention Type
Drug
Intervention Name(s)
Zolpidem Tartrate Tablets
Intervention Description
All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.
Primary Outcome Measure Information:
Title
The Coma Recovery Scale-Revised
Description
The consciousness was independently assessed using CRS-R six months after enrollment by a trained neurologist blinded to the clinical data. Patients who transitioned from UWS to MCS (UWS-MCS) or to emergence from MCS (EMCS) (UWS-EMCS), from MCS minus to MCS plus (MCS--MCS+) or to EMCS (MCS--EMCS), and from MCS to EMCS (MCS-EMCS) were categorized in the improved consciousness group. The unimproved consciousness was defined as a reduced or unchanged level of consciousness at six months.
Time Frame
Six months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission;
time since onset > 4 weeks;
no history of neurodegenerative or psychiatric diseases.
Exclusion Criteria:
allergic to zolpidem;
currently receiving zolpidem or related benzodiazepines;
diagnosed with seizure or status epilepticus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Jiang, doctor
Organizational Affiliation
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness
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