Clinical trial NCT05382260: Personal Music for Disorders of Consciousness
Official title: Can Personal Music Change the Functional Connectivity of Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder of Consciousness
Keywords: DOC
preferred music
functional connectivity
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional connectivity for Baseline EEG
timeFrame: After approximately 5 minutes baseline.
measure: Functional connectivity for relaxing music EEG
timeFrame: After approximately 5 minutes relaxing music.
measure: Functional connectivity for preferred music EEG
timeFrame: After approximately 5 minutes preferred music.
measure: Functional connectivity for amplitude modulated sound EEG
timeFrame: After approximately 6 minutes amplitude modulated sound.
Secondary outcomes:
measure: Heart Rate Variability(HRV) for baseline
timeFrame: After approximately 5 minutes baseline.
measure: Heart Rate Variability(HRV) for relaxing music
timeFrame: After approximately 5 minutes relaxing music.
measure: Heart Rate Variability(HRV) for preferred music
timeFrame: After approximately 5 minutes preferred music.
measure: Heart Rate Variability(HRV) for amplitude modulated sound
timeFrame: After approximately 6 minutes amplitude modulated sound.
measure: The Music Therapy Assessment Tool for Awareness in Disorders of Consciousness(MATADOC)
timeFrame: After approximately 5 minutes preferred music.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: