Personal Music for Disorders of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2023-12-31

Brief Summary

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Background: The evaluation and treatment of disorders of consciousness(DOC) is a challenging undertaking. Now many neuroimaging techniques were used to detect the level of consciousness and electroencephagram(EEG) was widely used because of its high temporal resolution. Music would be an effective for DOC, due to its highly arousal value. Preferred music was near to persons, so that it would excite more range of cortical and increase the functional connectivity between cortices.

Methods: The exploratory study included 15 health controls and 30 DOC, with 15 minimally conscious state(MCS) and 15 vegetative state(VS). After 5 minutes baseline silence, they listened to relaxing music(RM), preferred music(PM) and amplitude modulated sound(AMS), with 5 minutes baseline silence in the end, meanwhile EEG recorded their cortical activity. Each music was appropriately 5 minutes and separated by 3 minutes washout.

Discussion: The study would verify the effect of preferred music to the functional connectivity of DOC. Music would excite the networks related to consciousness by cross-modal.

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Detailed Description

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Conditions

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Disorder of Consciousness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Disorders of consciousness(DOC)

The participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS).

Group Type EXPERIMENTAL

Listening to music

Intervention Type OTHER

After 5 minutes baseline, participants would listen to three kinds of music with 3 minutes washout and another 5 minutes baseline in the end, while EEG would record their cortical activity. And the order of the three kinds of music is random.

Health control

They are health people with normal hearing, acting as a control for DOC group.

Group Type OTHER

Listening to music

Intervention Type OTHER

After 5 minutes baseline, participants would listen to three kinds of music with 3 minutes washout and another 5 minutes baseline in the end, while EEG would record their cortical activity. And the order of the three kinds of music is random.

Interventions

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Listening to music

After 5 minutes baseline, participants would listen to three kinds of music with 3 minutes washout and another 5 minutes baseline in the end, while EEG would record their cortical activity. And the order of the three kinds of music is random.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. being DOC less than 1 year and more than 28 days;
2. diagnosis of VS and MCS based on CRS-R;
3. the auditory sub-scale of CRS-R scoring more than 0, or Auditory Brainstem Response showing no auditory injury at least one side;
4. stopping using sedatives more than 24 hours prior to study;
5. no history of neurological or psychiatric diseases.

Exclusion Criteria

1. Auditory Brainstem Response showing completely injured auditory pathway(disappeared wave Ⅴ);
2. having epilepsy or EEG showing alpha-coma;
3. widely range of injured scalp or bone.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes