Personal Music for Disorders of Consciousness

NCT05382260 | Unknown

• 1 other identifier: L20220318
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Keywords

DOC; preferred music; functional connectivity

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  After approximately 6 minutes amplitude modulated sound.

Secondary Outcomes (5)

• Heart Rate Variability(HRV) for baseline

  After approximately 5 minutes baseline.

• Heart Rate Variability(HRV) for relaxing music

  After approximately 5 minutes relaxing music.

• Heart Rate Variability(HRV) for preferred music

  After approximately 5 minutes preferred music.

• Heart Rate Variability(HRV) for amplitude modulated sound

  After approximately 6 minutes amplitude modulated sound.

• The Music Therapy Assessment Tool for Awareness in Disorders of Consciousness(MATADOC)

  After approximately 5 minutes preferred music.

Study Arms (2)

Disorders of consciousness(DOC)

EXPERIMENTAL

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

Other: Listening to music

Health control

OTHER

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

Other: Listening to music

Interventions

Listening to music OTHER

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.

Disorders of consciousness(DOC); Health control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qiuyou Xie: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Qiuyi M Xiao, BSc

CONTACT

+8618302083474; 2936404912@qq.com

Qiuyou Xie, PhD

CONTACT

+8613903019604; 764942251@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 19, 2022
• Study Start: May 26, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

CN (1)