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Effects of Different Stimuli in Patients With Disorders of Consciousness

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03385291
Enrollment
28
Registered
2017-12-28
Start date
2015-07-01
Completion date
2017-07-30
Last updated
2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Consciousness

Keywords

EEG;DOC;auditory

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.

Interventions

DEVICEmusic,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

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Brain-damaged patients : 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.

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 : Inclusion Criteria: 1. Subjects with normal hearing 2. Absence of neurological disorder 3. Subjects able to understand the experimental instructions

Design outcomes

Primary

MeasureTime frameDescription
Glasgow Outcome Scale (GOS)In one yearA GOS value of \<3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery

Secondary

MeasureTime frameDescription
quantitative electroencephalography30 minutes before the auditory stimualtion and 30 minutes after each stimulationThe 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.

Other

MeasureTime frameDescription
N1,P300,LPPFrom 200 msec before the stimuli onset to 1000ms after the auditory stimulationThe event-related potential waveforms uncover voluntary responses to external stimuli that could assist in detecting signs of consciousness to reduce the risk of misdiagnosis.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026