Effects of Emotional Stimuli in Patients With Disorders of Consciousness

NCT ID: NCT03502837

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2017-08-30

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.

Conditions

Disorder of Consciousness

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy controls

age-matched right-handed healthy volunteers

emotional sound and neutral sound

Intervention Type: OTHER

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.

the mininally conscious state

Patients present reproducible signs of awareness such as purposeful eye movements or response to verbal order

emotional sound and neutral sound

Intervention Type: OTHER

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.

the vegetative state

Patients preserved autonomous functioning (e.g., preserved sleep-wake cycles),but without awareness of oneself or of the environment

emotional sound and neutral sound

Intervention Type: OTHER

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.

Interventions

emotional 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.

Intervention Type: OTHER

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 controls:

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

Locations

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

event-related potential

Identifier Type: -

Identifier Source: org_study_id