Personal Music for Disorders of Consciousness

Qiuyou Xie

Status: Enrolling

Conditions: Disorder of Consciousness

Treatments: Other: Listening to music

Study type: Interventional

Funder types: Other

Identifiers

NCT05382260

L20220318

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Disorders of consciousness(DOC)

Experimental group

Description:

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

Treatment:

Other: Listening to music

Health control

Other group

Description:

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

Treatment:

Other: Listening to music