NCT02948660

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

October 23, 2016

Last Update Submit

May 24, 2022

Conditions

Disorder of Consciousness

Keywords

Prolonged disorders of consciousnessZolpidemEEGPrognosisUnresponsive wakefulness syndromeMinimally conscious state

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six months after enrollment

Study Arms (2)

Patients with prolonged disorders of consciousness

EXPERIMENTAL

1. age ≥ 18 years; 2. presence of unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) on admission; 3. time since onset \> 4 weeks; 4. 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.

Drug: Zolpidem Tartrate Tablets

Healthy volunteers

EXPERIMENTAL

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.

Drug: Zolpidem Tartrate Tablets

Interventions

Zolpidem Tartrate TabletsDRUG

All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.

Healthy volunteersPatients with prolonged disorders of consciousness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • allergic to zolpidem;
  • currently receiving zolpidem or related benzodiazepines;
  • diagnosed with seizure or status epilepticus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Consciousness DisordersPersistent Vegetative State

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesUnconsciousness

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wen Jiang, doctor

    Department of Neurology, Xijing Hospital, Fourth Military Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2016

First Posted

October 28, 2016

Study Start

December 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

May 31, 2022

Record last verified: 2022-03

Locations

CN(1)