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Effects of Emotional Stimuli in Patients With Disorders of Consciousness

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03502837
Enrollment
60
Registered
2018-04-19
Start date
2015-02-01
Completion date
2017-08-30
Last updated
2018-04-19

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

Conditions

Disorder of Consciousness

Keywords

ERP;DOC;auditory

Brief summary

Disentangling the vegetative state from the minimally conscious state is often difficult when relying only on behavioral observation. In this study, the investigators explored a new event-related potential paradigm as an alternative method for the detection of voluntary brain activity and cognitive abilities in the patients with disorders of consciousness.

Detailed description

Auditory emotional stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (DOC); 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 emotional stimuli using ERP(Event-related potential),and further investigated the brain activation network.

Interventions

OTHERemotional sound and neutral sound

Neutral voice is a meaningless sound (namely the interjection ah) and the emotional stimuli were the same voice pronouncing the same word with an emotional prosody of happiness or sadness.The stimulus material consisted of positive and negative sound selected from the International Affective Digitalized Sounds (IADS) database.In order to identify experimental stimuli sets that were matched for ratings of arousal and valence between the two valence types,investigators used an algorithm to equate normative valence and arousal ratings for the selection of auditory stimuli.

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

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 controls: 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
electrophysiological index:the cognitive event-related potentional componentsfrom 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. P300 is a large positive going potential that increases in amplitude from the frontal to parietal electrodes and has a peak latency of about 300 ms for auditory and 400 ms for visual stimuli. And N1 is a negative potential in the posterior superior temporal lobe with the peak latency of about 170ms.Peak amplitudes and latency were obtained for the interest ERP components(N1,P300) .Peak amplitudes and latency for were analysed in a series of repeated-measures ANOVAs for each component (N1, P2), with factors of condition (emotion: mean happy/angry vs. neutral).

Secondary

MeasureTime frameDescription
CRS-R(Coma Recovery Scale-Revised)30 minutes before the auditory stimualtion and 30 minutes after each stimulationCRS-R has been designed to differentiate VS from MCS and consists of 23 hierarchically arranged items that comprise six subscales addressing arousal, auditory, visual, motor, oromotor/verbal, and communication functions. The lowest item on each subscale represents reflexive activity while the highest item represents cognitively mediated behaviors.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026