Vegetative StateNCT03492294
The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study
An observational study of Vegetative State and Minimally Conscious State, run by Hangzhou Normal University at 1 site in China.
Trial summary
The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 21 to 61 years
- Conditions the study is for
- Vegetative State, Minimally Conscious State
- What is being tested?
- functional magnetic resonance imaging
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Apr 2018
- Phase
- Observational
- 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 21 to 61 years
- All sexes
- Adult
Study population: patients with disorders of consciousness
Who may be able to join
- age ≥ 18 years old;
- no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
- brain damage with eye opening (indicating wakefulness and rest cycles)
Who cannot join
- Coma;
- neurodegenerative disease;
- psychiatric or neurologic illness;
- with intracranial metal or other body metal.
Trial locations and contacts
1 site in 1 country.
China1 site
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang, 3100036
About this study
The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).
Read the detailed description
Background: Sensory stimulations were used widely to evaluate the preserved cerebral functions for these patients with disorders of consciousness. Among these, the most alerting or common stimuli are probably familiar voice and music.
Objective: The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).
Methods: Eleven severely brain-damaged patients (6 UWS and 5 MCS) were assessed by functional magnetic resonance imaging while they were exposed under the condition of their personal music. To examine the prognostic value of these patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R after fMRI acquisition.
- Conditions
- Vegetative State, Minimally Conscious State
- Being tested
- functional magnetic resonance imaging
- Keywords
- disorders of consciousness, music stimulation, functional magnetic resonance imaging
- Medical subject headings
- Persistent Vegetative State, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imagingDiagnostic test
Also called Coma Recovery Scale-Revised
Patients with disorders of consciousness were assessed by functional magnetic resonance imaging while they were exposed under the condition of music.
| Study group | Role | What they receive |
|---|---|---|
| patients with disorders of consciousness | patients with disorders of consciousness from several brain injury have been clinically classified into coma, unresponsive wakefulness syndrome and minimally conscious state. These patients were scaned by functional magnetic resonance imaging. Receives: Diagnostic Test: functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-Revised
examine the prognostic value of these patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R after fMRI acquisition
Measured: one to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study startDec 2008
- Primary completionNov 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vegetative StateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Wang, Hangzhou Normal University
- Investigators
- Haibo Di, Pro, Study chair, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492294
- Sponsor's protocol ID
- 2008W1224
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Owen AM, Coleman MR. Detecting awareness in the vegetative state. Ann N Y Acad Sci. 2008;1129:130-8. doi: 10.1196/annals.1417.018.
PubMed 18591475
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study
- ClinicalTrials.gov ID
- NCT03492294
- Acronym / sponsor ID
- 2008W1224
- Conditions
- Vegetative State, Minimally Conscious State
- Keywords
- disorders of consciousness, music stimulation, functional magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- Dec 2008 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- 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 aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).
Detailed description
Background: Sensory stimulations were used widely to evaluate the preserved cerebral functions for these patients with disorders of consciousness. Among these, the most alerting or common stimuli are probably familiar voice and music.
Objective: The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).
Methods: Eleven severely brain-damaged patients (6 UWS and 5 MCS) were assessed by functional magnetic resonance imaging while they were exposed under the condition of their personal music. To examine the prognostic value of these patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R after fMRI acquisition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with disorders of consciousness | – | Diagnostic Test: functional magnetic resonance imagingpatients with disorders of consciousness from several brain injury have been clinically classified into coma, unresponsive wakefulness syndrome and minimally conscious state. These patients were scaned by functional magnetic resonance imaging. |
Who may qualify
- Ages
- 21 to 61 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients with disorders of consciousness
Key inclusion criteria (3 listed)
- age ≥ 18 years old;
- no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
- brain damage with eye opening (indicating wakefulness and rest cycles)
Key exclusion criteria (4 listed)
- Coma;
- neurodegenerative disease;
- psychiatric or neurologic illness;
- with intracranial metal or other body metal.
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 |
|---|---|---|
| functional magnetic resonance imagingAlso: Coma Recovery Scale-RevisedPatients with disorders of consciousness were assessed by functional magnetic resonance imaging while they were exposed under the condition of music. | Diagnostic test | patients with disorders of consciousness |
Primary outcome
Coma Recovery Scale-Revised
Time frame: one to two years
examine the prognostic value of these patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R after fMRI acquisition
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 10 Apr 2018.
- Background: PubMed 18591475Owen AM, Coleman MR. Detecting awareness in the vegetative state. Ann N Y Acad Sci. 2008;1129:130-8. doi: 10.1196/annals.1417.018.
- Individual participant dataSharing planned: Yes
Related trials for Vegetative State
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Temporal Interference Stimulation for Disorders of Consciousness
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AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness
Disorders of Consciousness, Vegetative State
Not yet recruitingObservational study
Multimodal Assessment and Prognosis in Disorders of Consciousness After Severe Brain Injury (CyDoC-MAP)
Consciousness Disorders, Persistent Vegetative State
Enrolling by invitation
Prognostication of Recovery in Early Disorders of Consciousness Study
Disorder of Consciousness, Comatose
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.
Haibo Di, Pro study chair
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vegetative State and Minimally Conscious State, run by Hangzhou Normal University 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 4 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 10 Apr 2018. 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.
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?
Coma Recovery Scale-Revised (time frame: one to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492294, which also lists 1 linked publication.
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 10 Apr 2018.