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Personal Music for Disorders of Consciousness

Primary Purpose

Disorder of Consciousness

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Listening to music
Sponsored by
Qiuyou Xie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Consciousness focused on measuring DOC, preferred music, functional connectivity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Zhujiang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Disorders of consciousness(DOC)

Health control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 1, 2022
Last Updated
January 20, 2023
Sponsor
Qiuyou Xie
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1. Study Identification

Unique Protocol Identification Number
NCT05382260
Brief Title
Personal Music for Disorders of Consciousness
Official Title
Can Personal Music Change the Functional Connectivity of Disorders of Consciousness
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qiuyou Xie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
Keywords
DOC, preferred music, functional connectivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Disorders of consciousness(DOC)
Arm Type
Experimental
Arm Description
The participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS).
Arm Title
Health control
Arm Type
Other
Arm Description
They are health people with normal hearing, acting as a control for DOC group.
Intervention Type
Other
Intervention Name(s)
Listening to music
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional connectivity for Baseline EEG
Description
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.
Time Frame
After approximately 5 minutes baseline.
Title
Functional connectivity for relaxing music EEG
Description
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.
Time Frame
After approximately 5 minutes relaxing music.
Title
Functional connectivity for preferred music EEG
Description
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.
Time Frame
After approximately 5 minutes preferred music.
Title
Functional connectivity for amplitude modulated sound EEG
Description
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.
Time Frame
After approximately 6 minutes amplitude modulated sound.
Secondary Outcome Measure Information:
Title
Heart Rate Variability(HRV) for baseline
Description
Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.
Time Frame
After approximately 5 minutes baseline.
Title
Heart Rate Variability(HRV) for relaxing music
Description
Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.
Time Frame
After approximately 5 minutes relaxing music.
Title
Heart Rate Variability(HRV) for preferred music
Description
Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.
Time Frame
After approximately 5 minutes preferred music.
Title
Heart Rate Variability(HRV) for amplitude modulated sound
Description
Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline.
Time Frame
After approximately 6 minutes amplitude modulated sound.
Title
The Music Therapy Assessment Tool for Awareness in Disorders of Consciousness(MATADOC)
Description
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.
Time Frame
After approximately 5 minutes preferred music.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: being DOC less than 1 year and more than 28 days; diagnosis of VS and MCS based on CRS-R; the auditory sub-scale of CRS-R scoring more than 0, or Auditory Brainstem Response showing no auditory injury at least one side; stopping using sedatives more than 24 hours prior to study; no history of neurological or psychiatric diseases. Exclusion Criteria: Auditory Brainstem Response showing completely injured auditory pathway(disappeared wave Ⅴ); having epilepsy or EEG showing alpha-coma; widely range of injured scalp or bone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiuyi M Xiao, BSc
Phone
+8618302083474
Email
2936404912@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiuyou Xie, PhD
Phone
+8613903019604
Email
764942251@qq.com
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuyou Xie, PhD
Phone
+86 139 0301 9604
Email
764942251@qq.com

12. IPD Sharing Statement

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Personal Music for Disorders of Consciousness

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