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

April 3, 2018 updated by: Jing Wang, Hangzhou Normal University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 3100036
        • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 61 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with disorders of consciousness

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patients with disorders of consciousness were assessed by functional magnetic resonance imaging while they were exposed under the condition of music.
Other Names:
  • Coma Recovery Scale-Revised

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Normal University

Investigators

  • Study Chair: Haibo Di, Pro, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008W1224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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