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Personal Music for Disorders of Consciousness

Can Personal Music Change the Functional Connectivity of Disorders of Consciousness

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05382260
Enrollment
45
Registered
2022-05-19
Start date
2022-05-26
Completion date
2023-12-31
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

Keywords

DOC, preferred music, functional connectivity

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.

Interventions

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.

Sponsors

Qiuyou Xie
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.
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.
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.

Countries

China

Contacts

Primary ContactQiuyi M Xiao, BSc
2936404912@qq.com+8618302083474
Backup ContactQiuyou Xie, PhD
764942251@qq.com+8613903019604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026