EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The Coma Recovery Scale-Revised
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Patients with prolonged disorders of consciousness
- 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.
Intervention: Zolpidem Tartrate Tablets (Drug)
Healthy volunteers
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.
Intervention: Zolpidem Tartrate Tablets (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported