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

Study Overview
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Brief Summary
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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.

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

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Drug: Zolpidem Tartrate Tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with prolonged disorders of consciousness<br>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<br>* All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.<br>|
| Experimental: Healthy volunteers<br>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<br>* All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, Prolonged disorders of consciousness, Zolpidem, Prognosis, Unresponsive wakefulness syndrome, Minimally conscious state