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Clinical Trials/NCT02948660
NCT02948660CompletedPhase 2

EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness

Xijing Hospital1 site in 1 country36 target enrollmentStarted: December 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
The Coma Recovery Scale-Revised

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: Zolpidem Tartrate Tablets (Drug)

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.

Intervention: Zolpidem Tartrate Tablets (Drug)

Outcomes

Primary Outcomes

The Coma Recovery Scale-Revised

Time Frame: Six months after enrollment

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Xijing Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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