Disorder of ConsciousnessPhase 2NCT02948660
A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness
A Phase 2 study testing Zolpidem Tartrate Tablets in people with Disorder of Consciousness, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Zolpidem Tartrate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 30 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- allergic to zolpidem;
- currently receiving zolpidem or related benzodiazepines;
- diagnosed with seizure or status epilepticus.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness
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
- Being tested
- Zolpidem Tartrate Tablets
- Keywords
- Prolonged disorders of consciousness, Zolpidem, EEG, Prognosis, Unresponsive wakefulness syndrome, Minimally conscious state
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem Tartrate TabletsDrug
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 group | Role | What they receive |
|---|---|---|
| Patients with prolonged disorders of consciousness | Experimental | 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. Receives: Drug: Zolpidem Tartrate Tablets |
| Healthy volunteers | Experimental | 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. Receives: Drug: Zolpidem Tartrate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start1 Dec 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou University of Chinese Medicine, University of Melbourne, Tianjin University
- Responsible party
- Sponsor
- Investigators
- Wen Jiang, doctor, Study director, Department of Neurology, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948660
- Sponsor's protocol ID
- 81571262
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2016
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Dynamics Induced by Zolpidem Forecasts Consciousness Evolution in Prolonged Disorders of Consciousness and Quantification of EEG Reactivity Predicts Recovery of Consciousness
- ClinicalTrials.gov ID
- NCT02948660
- Acronym / sponsor ID
- 81571262
- Conditions
- Disorder of Consciousness
- Keywords
- Prolonged disorders of consciousness, Zolpidem, EEG, Prognosis, Unresponsive wakefulness syndrome, Minimally conscious state
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Guangzhou University of Chinese Medicine, University of Melbourne, Tianjin University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with prolonged disorders of consciousness | Experimental | Drug: Zolpidem Tartrate Tablets1. 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. |
| Healthy volunteers | Experimental | Drug: Zolpidem Tartrate TabletsHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- allergic to zolpidem;
- currently receiving zolpidem or related benzodiazepines;
- diagnosed with seizure or status epilepticus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolpidem Tartrate TabletsAll participants were administered 10 mg of zolpidem tartrate tablets either via a feeding tube (for patients with prolonged disorders of consciousness) or orally. | Drug | Healthy volunteers, Patients with prolonged disorders of consciousness |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Jiang, doctor study director
Department of Neurology, Xijing Hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zolpidem Tartrate Tablets in people with Disorder of Consciousness, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Coma Recovery Scale-Revised (time frame: Six months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.