A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness

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

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 Overview

• Status: Completed
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Drug: Zolpidem Tartrate Tablets

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Department of Neurology, Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with prolonged disorders of consciousness; 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.	Drug: Zolpidem Tartrate Tablets; All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.
EXPERIMENTAL: Healthy volunteers; 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; All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Guangzhou University of Chinese Medicine; University of Melbourne; Tianjin University
• Investigators: Study Director: Wen Jiang, doctor, Department of Neurology, Xijing Hospital, Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: October 23, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (ESTIMATE): October 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Prognosis; EEG; Zolpidem; Minimally conscious state; Unresponsive wakefulness syndrome; Prolonged disorders of consciousness
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease; Consciousness Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: 81571262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No