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

NCT ID: NCT02948660

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-06-30

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.

Conditions

Disorder of Consciousness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Patients with prolonged disorders of consciousness

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.

Group Type: EXPERIMENTAL

Zolpidem Tartrate Tablets

Intervention Type: DRUG

All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.

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.

Group Type: EXPERIMENTAL

Zolpidem Tartrate Tablets

Intervention Type: DRUG

All participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou University of Chinese Medicine

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

Tianjin University

OTHER

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen Jiang, doctor

Role: STUDY_DIRECTOR

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Locations

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

81571262

Identifier Type: -

Identifier Source: org_study_id