Effects of Emotional Stimuli in Patients With Disorders of Consciousness

Completed

• Conditions: Disorder of Consciousness
• Interventions: Other: emotional sound and neutral sound

• Registration Number: NCT03502837
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2017-07-30
• Study Completion: 2017-08-30
• Status Verified: 2017-09
• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Study First Posted: 2018-04-19
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
electrophysiological index:the cognitive event-related potentional components	from 200 msec before the stimuli onset to 1000ms after the auditory stimulation	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).

Secondary Outcome Measures

Name	Time	Method
CRS-R(Coma Recovery Scale-Revised)	30 minutes before the auditory stimualtion and 30 minutes after each stimulation	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.

Trial Locations

Locations (1)

Hangzhou Hospital of Zhejiang CAPR; 🇨🇳 Hangzhou, Zhejiang, China