Effects of Emotional Stimuli in Patients With Disorders of Consciousness

April 17, 2018 updated by: First Affiliated Hospital of Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
electrophysiological index:the cognitive event-related potentional components
Time Frame: 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).
from 200 msec before the stimuli onset to 1000ms after the auditory stimulation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CRS-R(Coma Recovery Scale-Revised)
Time Frame: 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.
30 minutes before the auditory stimualtion and 30 minutes after each stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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