Effects of Emotional Stimuli in Patients With Disorders of Consciousness

NCT03502837 | Completed

• 1 other identifier: event-related potential
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Keywords

ERP;DOC;auditory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CRS-R(Coma Recovery Scale-Revised)

  30 minutes before the auditory stimualtion and 30 minutes after each stimulation

Study Arms (3)

Healthy controls

age-matched right-handed healthy volunteers

Other: emotional sound and neutral sound

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

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

Interventions

emotional sound and neutral sound 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.

Healthy controls; the mininally conscious state; the vegetative state

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
• Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
• Lack of autonomic crisis since one week minimum
• Medical condition considered stable
• Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

You may not qualify if:

• hearing Problem
• Uncontrolled Epilepsy
• Autonomic crises
• Medical unstable state
• Pregnant or likely to be (interrogation data) or breastfeeding woman
• Healthy controls:
• Subjects with normal hearing
• Absence of neurological disorder
• Subjects able to understand the experimental instructions
• Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
• Neurological disorders
• Pregnant or likely to be (interrogation data) or breastfeeding woman

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benyan Luo

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: April 19, 2018
• Study Start: February 1, 2015
• Primary Completion: July 30, 2017
• Study Completion: August 30, 2017
• Last Updated: April 19, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)