Disorder of ConsciousnessNCT05382260
Personal Music for Disorders of Consciousness
A study testing Listening to music in people with Disorder of Consciousness, run by Qiuyou Xie at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Listening to music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Qiuyou Xie, PhD, +86 139 0301 9604, 764942251@qq.com
About this study
Official title: 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.
- Conditions
- Disorder of Consciousness
- Being tested
- Listening to music
- Keywords
- DOC, preferred music, functional connectivity
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to musicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Disorders of consciousness(DOC) | Experimental | The participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS). Receives: Other: Listening to music |
| Health control | Other | They are health people with normal hearing, acting as a control for DOC group. Receives: Other: Listening to music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After approximately 6 minutes amplitude modulated sound.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After approximately 5 minutes preferred music.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start26 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiuyou Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiuyou Xie, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382260
- Sponsor's protocol ID
- L20220318
- Status last verified
- Jan 2023
- First submitted
- 1 Apr 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Personal Music Change the Functional Connectivity of Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT05382260
- Acronym / sponsor ID
- L20220318
- Conditions
- Disorder of Consciousness
- Keywords
- DOC, preferred music, functional connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Qiuyou XieUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disorders of consciousness(DOC) | Experimental | Other: Listening to musicThe participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS). |
| Health control | Other | Other: Listening to musicThey are health people with normal hearing, acting as a control for DOC group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening to musicAfter 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 | Disorders of consciousness(DOC), Health control |
Primary outcome
Functional connectivity for Baseline EEG
Time frame: After 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 EEG
Time frame: After 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 EEG
Time frame: After 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 EEG
Time frame: After 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.
5 secondary outcomes
Heart Rate Variability(HRV) for baseline
Time frame: After approximately 5 minutes baseline.
Heart Rate Variability(HRV) for relaxing music
Time frame: After approximately 5 minutes relaxing music.
Heart Rate Variability(HRV) for preferred music
Time frame: After approximately 5 minutes preferred music.
Heart Rate Variability(HRV) for amplitude modulated sound
Time frame: After approximately 6 minutes amplitude modulated sound.
The Music Therapy Assessment Tool for Awareness in Disorders of Consciousness(MATADOC)
Time frame: After approximately 5 minutes preferred music.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to music in people with Disorder of Consciousness, run by Qiuyou Xie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiuyi M Xiao, BSc (+8618302083474, 2936404912@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity for Baseline EEG (time frame: After approximately 5 minutes baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.