Effects of Different Stimuli in Patients With Disorders of Consciousness

NCT ID: NCT03385291

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2017-07-30

Brief Summary

In recent years, promoting wakening attempts in patients with disorders of consciousness are increasing, but there are a lack of objective indicators to evaluate the efficacy and further researches on the brain mechanism during the wakening processing. So, the study first assessed the cerebral response during emotional acoustic stimuli with quantitative EEG and ERP(Event-related potential), and next, the investigators explored the relationship between brain activation and patients' recovery.

Detailed Description

Auditory stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (DOC)，especially the emotional sound; however, precise and accurate quantitative indices to estimate cerebral activation to different auditory stimuli remain scarce. In this study, investigators assessed the response of different brain regions to three acoustic stimuli using quantitative electroencephalography (QEEG) and ERP(Event-related potential),and further investigated the predictive value of QEEG in the prognosis of DOC.

Conditions

Disorder of Consciousness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with disorders of consciousness

3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.

Group Type: EXPERIMENTAL

music,name,and noise sound

Intervention Type: DEVICE

A 5-minute baseline silence was followed by the presentation of three contrasting auditory stimuli(music,name,and noise), with a 2-minute washout silence separating each stimulus

healthy control group

3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.

Group Type: EXPERIMENTAL

music,name,and noise sound

Intervention Type: DEVICE

A 5-minute baseline silence was followed by the presentation of three contrasting auditory stimuli(music,name,and noise), with a 2-minute washout silence separating each stimulus

Interventions

music,name,and noise sound

A 5-minute baseline silence was followed by the presentation of three contrasting auditory stimuli(music,name,and noise), with a 2-minute washout silence separating each stimulus

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)

2. Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)

3. Lack of autonomic crisis since one week minimum

4. Medical condition considered stable

5. Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

1. Subjects with normal hearing

2. Absence of neurological disorder

3. Subjects able to understand the experimental instructions

Exclusion Criteria

1. hearing Problem

2. Uncontrolled Epilepsy

3. Autonomic crises

4. Medical unstable state

5. Pregnant or likely to be (interrogation data) or breastfeeding woman

Healthy participants :

1. Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz

2. Neurological disorders

3. Pregnant or likely to be (interrogation data) or breastfeeding woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benyan Luo

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

References

Wu M, Bao WX, Zhang J, Hu YF, Gao J, Luo BY. Effect of acoustic stimuli in patients with disorders of consciousness: a quantitative electroencephalography study. Neural Regen Res. 2018 Nov;13(11):1900-1906. doi: 10.4103/1673-5374.238622.

Reference Type: DERIVED

PMID: 30233062 (View on PubMed)

Other Identifiers

disorders of consciousness

Identifier Type: -

Identifier Source: org_study_id