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

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Disorder of Consciousness

Treatments: Drug: Zolpidem Tartrate Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT02948660

81571262

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Patients with prolonged disorders of consciousness

Experimental group

Description:

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.

Treatment:

Drug: Zolpidem Tartrate Tablets

Healthy volunteers

Experimental group

Description:

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.

Treatment:

Drug: Zolpidem Tartrate Tablets