Personal Music for Disorders of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

Can Personal Music Change the Functional Connectivity of Disorders of Consciousness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382260
• Other study ID #: L20220318
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Zhujiang Hospital
• Contact: Qiuyi M Xiao, BSc
• Phone: +8618302083474
• Email: 2936404912[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ?);

2. having epilepsy or EEG showing alpha-coma;

3. widely range of injured scalp or bone.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Qiuyou Xie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional connectivity for Baseline EEG	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: d (1-4 Hz), ? (4-8 Hz), a (8-13 Hz), ß (13-30 Hz), and ? (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.	After approximately 5 minutes baseline.
Primary	Functional connectivity for relaxing music EEG	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: d (1-4 Hz), ? (4-8 Hz), a (8-13 Hz), ß (13-30 Hz), and ? (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.	After approximately 5 minutes relaxing music.
Primary	Functional connectivity for preferred music EEG	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: d (1-4 Hz), ? (4-8 Hz), a (8-13 Hz), ß (13-30 Hz), and ? (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.	After approximately 5 minutes preferred music.
Primary	Functional connectivity for amplitude modulated sound EEG	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: d (1-4 Hz), ? (4-8 Hz), a (8-13 Hz), ß (13-30 Hz), and ? (30-45 Hz) and the functional connectivity would be calculated by each frequency bands.	After approximately 6 minutes amplitude modulated sound.
Secondary	Heart Rate Variability(HRV) for baseline	Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.	After approximately 5 minutes baseline.
Secondary	Heart Rate Variability(HRV) for relaxing music	Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.	After approximately 5 minutes relaxing music.
Secondary	Heart Rate Variability(HRV) for preferred music	Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.	After approximately 5 minutes preferred music.
Secondary	Heart Rate Variability(HRV) for amplitude modulated sound	Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.	After approximately 6 minutes amplitude modulated sound.
Secondary	The Music Therapy Assessment Tool for Awareness in Disorders of Consciousness(MATADOC)	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.	After approximately 5 minutes preferred music.