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

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Consciousness
• Intervention / Treatment: Other: emotional sound and neutral sound

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou Hospital of Zhejiang CAPR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

30 healthy controls and 30 patients in dicorders of consciousness(15 VS and 15 MCS)

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls; age-matched right-handed healthy volunteers	Other: 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.
the mininally conscious state; Patients present reproducible signs of awareness such as purposeful eye movements or response to verbal order	Other: 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.
the vegetative state; Patients preserved autonomous functioning (e.g., preserved sleep-wake cycles),but without awareness of oneself or of the environment	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electrophysiological index:the cognitive event-related potentional components	The 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).	from 200 msec before the stimuli onset to 1000ms after the auditory stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRS-R(Coma Recovery Scale-Revised)	CRS-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.	30 minutes before the auditory stimualtion and 30 minutes after each stimulation

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: March 18, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: ERP;DOC;auditory
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: event-related potential

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No