An interventional study of Listening to music in Disorder of Consciousness, sponsored by Qiuyou Xie. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by Qiuyou Xie · Not applicable, Interventional, and Treatment
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.
236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.
This study's planned enrollment of 45 is above the median of 40 across 147 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Qiuyou Xie is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS).
Other: Listening to music
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After approximately 6 minutes amplitude modulated sound.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After approximately 5 minutes preferred music.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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