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CompletedNCT03492294Updated Apr 10, 2018

The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study

An observational study in Vegetative State and Minimally Conscious State, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 21 Years to 61 Years. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by Hangzhou Normal University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
21 Years to 61 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Vegetative State
  • Minimally Conscious State

Keywords

  • disorders of consciousness
  • music stimulation
  • functional magnetic resonance imaging
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In context

Persistent Vegetative State

88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.

This study's enrollment of 11 is below the median of 80 across 31 observational studies indexed under Persistent Vegetative State.

Browse Persistent Vegetative State studies →

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 61 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

patients with disorders of consciousness

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Coma;
  • neurodegenerative disease;
  • psychiatric or neurologic illness;
  • with intracranial metal or other body metal.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: functional magnetic resonance imaging

Interventions

  • Diagnostic testfunctional magnetic resonance imaging

    Patients with disorders of consciousness were assessed by functional magnetic resonance imaging while they were exposed under the condition of music.

    Also known as: Coma Recovery Scale-Revised

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What researchers measure

Primary outcomes

  1. 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

    Time frame: one to two years

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Study locations

1 site
  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
    Hangzhou, Zhejiang 3100036, China
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References and documents

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 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03492294
Lead sponsor
Hangzhou Normal University
Responsible party
Jing Wang (Dr, Hangzhou Normal University) — Principal investigator
First posted
Apr 10, 2018
Start date
Dec 2008
Primary completion
Nov 2017
Completion
Apr 2018
Last update
Apr 10, 2018

Study contacts

Haibo Di, Pro
study chair · International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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