Effects of Different Stimuli in Patients With Disorders of Consciousness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Acoustic Stimuli in Patients With Disorders of Consciousness: An Electroencephalography and Neuroimaging Study

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Device: music,name,and noise sound


Participation Criteria
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Eligibility Criteria
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Brain-damaged patients : Inclusion Criteria: Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy) Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002) Lack of autonomic crisis since one week minimum Medical condition considered stable Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal. Exclusion Criteria: hearing Problem Uncontrolled Epilepsy Autonomic crises Medical unstable state Pregnant or likely to be (interrogation data) or breastfeeding woman Healthy participants : Inclusion Criteria: Subjects with normal hearing Absence of neurological disorder Subjects able to understand the experimental instructions Exclusion Criteria: Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz Neurological disorders Pregnant or likely to be (interrogation data) or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with disorders of consciousness<br>3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period. | Device: music,name,and noise sound<br>* 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<br>|
| Experimental: healthy control group<br>3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period. | Device: music,name,and noise sound<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale (GOS) | A GOS value of <3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery | In one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative electroencephalography | The power spectrum was divided into four bandwidths,an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC. The power of α and β is related to the chance of recovery. | 30 minutes before the auditory stimualtion and 30 minutes after each stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG;DOC;auditory