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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02948660

Enrollment

Registered

2016-10-28

Start date

2017-12-01

Completion date

2019-06-30

Last updated

2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

Keywords

Prolonged disorders of consciousness, Zolpidem, EEG, Prognosis, Unresponsive wakefulness syndrome, Minimally conscious state

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.

Interventions

DRUGZolpidem 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026