Clinical trial NCT03385291: Effects of Different Stimuli in Patients With Disorders of Consciousness
Official title: Effects of Acoustic Stimuli in Patients With Disorders of Consciousness: An Electroencephalography and Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Consciousness
Keywords: EEG;DOC;auditory
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Exclusion Criteria:

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

Primary outcomes:
measure: Glasgow Outcome Scale (GOS)
timeFrame: In one year
Secondary outcomes:
measure: quantitative electroencephalography
timeFrame: 30 minutes before the auditory stimualtion and 30 minutes after each stimulation
Other outcomes:
measure: N1,P300,LPP
timeFrame: From 200 msec before the stimuli onset to 1000ms after the auditory stimulation
Locations:
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Benyan Luo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.