MedPath

Personal Music for Disorders of Consciousness

Not Applicable
Recruiting
Conditions
Disorder of Consciousness
Interventions
Other: Listening to music
Registration Number
NCT05382260
Lead Sponsor
Qiuyou Xie
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
45
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Disorders of consciousness(DOC)Listening to musicThe participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS).
Health controlListening to musicThey are health people with normal hearing, acting as a control for DOC group.
Primary Outcome Measures
NameTimeMethod
Functional connectivity for Baseline EEGAfter approximately 5 minutes baseline.

EEG would record participants' cortical activity while they are keeping quiet with their eyes opened for 5 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.

Functional connectivity for relaxing music EEGAfter approximately 5 minutes relaxing music.

EEG would record participants' cortical activity while they are listening to relaxing music for approximately 5 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.

Functional connectivity for preferred music EEGAfter approximately 5 minutes preferred music.

EEG would record participants' cortical activity while they are listening to preferred music for approximately 5 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.

Functional connectivity for amplitude modulated sound EEGAfter approximately 6 minutes amplitude modulated sound.

EEG would record participants' cortical activity while they are listening to amplitude modulation sound for approximately 6 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.

Secondary Outcome Measures
NameTimeMethod
Heart Rate Variability(HRV) for baselineAfter approximately 5 minutes baseline.

Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.

Heart Rate Variability(HRV) for relaxing musicAfter approximately 5 minutes relaxing music.

Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.

Heart Rate Variability(HRV) for preferred musicAfter approximately 5 minutes preferred music.

Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.

Heart Rate Variability(HRV) for amplitude modulated soundAfter approximately 6 minutes amplitude modulated sound.

Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.

The Music Therapy Assessment Tool for Awareness in Disorders of Consciousness(MATADOC)After approximately 5 minutes preferred music.

A scale contains three sub-scale, such as Principal Subscale: Essential Categories(scoring from 0 to 17, with the higher scores, the better status), Musical parameter and behavioural response type(scoring from 13 to 26, with the higher scores, the better status), Clinical information to inform goal setting and clinical care. The music therapist would give score from watching the video after study.

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University

🇨🇳

Guangzhou, Guangdong, China

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