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

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948660
• Other study ID #: 81571262
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2022
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disease
• Disorder of Consciousness

Intervention

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.

Locations

Country	Name	City	State
China	Department of Neurology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
Xijing Hospital	Guangzhou University of Chinese Medicine, Tianjin University, University of Melbourne

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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