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Completed

NCT Number: NCT02948660

A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders 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.

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Key information

Conditions

Disorder of Consciousness Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zolpidem Tartrate Tablets

Drug

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

  • Guangzhou University of Chinese Medicine
  • Tianjin University
  • University of Melbourne

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 28, 2016
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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