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

Minimally Conscious State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492294
• Other study ID #: 2008W1224
• Status: Completed
• First received: April 3, 2018
• Last updated: April 3, 2018
• Start date: December 2008
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2018
• Est. primary completion date: November 2017
• Gender: All
• Age group: 21 Years to 61 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

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.

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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