NCT03492294

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

8.9 years

First QC Date

April 3, 2018

Last Update Submit

April 3, 2018

Conditions

Keywords

disorders of consciousnessmusic stimulationfunctional magnetic resonance imaging

Outcome Measures

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

    one to two years

Study Arms (1)

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

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
patients with disorders of consciousness

Eligibility Criteria

Age21 Years - 61 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients with disorders of consciousness

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

Location

Related Publications (1)

  • 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.

    PMID: 18591475BACKGROUND

MeSH Terms

Conditions

Persistent Vegetative StateConsciousness Disorders

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesUnconsciousnessNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Haibo Di, Pro

    International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 10, 2018

Study Start

December 1, 2008

Primary Completion

November 1, 2017

Study Completion

April 1, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Locations