Personal Music for Disorders of Consciousness

Can Personal Music Change the Functional Connectivity of Disorders of Consciousness

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.

Study Overview

• Status: Recruiting
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Other: Listening to music

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiuyi M Xiao, BSc; Phone Number: +8618302083474; Email: 2936404912@qq.com
• Study Contact Backup: Name: Qiuyou Xie, PhD; Phone Number: +8613903019604; Email: 764942251@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Zhujiang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disorders of consciousness(DOC); The participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS).	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.
Other: Health control; They are health people with normal hearing, acting as a control for DOC group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.	After approximately 5 minutes baseline.
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: 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.	After approximately 5 minutes relaxing music.
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: 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.	After approximately 5 minutes preferred music.
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: 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.	After approximately 6 minutes amplitude modulated sound.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Qiuyou Xie

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: functional connectivity; DOC; preferred music
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: L20220318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No