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

Phase 2

Completed

• Conditions: Disorder of Consciousness
• Interventions: Drug: Zolpidem Tartrate Tablets

• Registration Number: NCT02948660
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-23
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Study Start: 2017-12-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Zolpidem Tartrate Tablets	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.
Patients with prolonged disorders of consciousness	Zolpidem Tartrate Tablets	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.

Primary Outcome Measures

Name	Time	Method
The Coma Recovery Scale-Revised	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.

Trial Locations

Locations (1)

Department of Neurology, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China