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Effects of Different Stimuli in Patients With Disorders of Consciousness

Primary Purpose

Disorder of Consciousness

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

music,name,and noise sound

About this trial

This is an interventional treatment trial for Disorder of Consciousness focused on measuring EEG;DOC;auditory

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Brain-damaged patients :

Inclusion Criteria:

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.

Exclusion Criteria:

hearing Problem
Uncontrolled Epilepsy
Autonomic crises
Medical unstable state
Pregnant or likely to be (interrogation data) or breastfeeding woman

Healthy participants :

Inclusion Criteria:

Subjects with normal hearing
Absence of neurological disorder
Subjects able to understand the experimental instructions

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

patients with disorders of consciousness

healthy control group

Arm Description

3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.

Outcomes

Primary Outcome Measures

Glasgow Outcome Scale (GOS)

A GOS value of <3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery

Secondary Outcome Measures

quantitative electroencephalography

The power spectrum was divided into four bandwidths,an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC. The power of α and β is related to the chance of recovery.

Full Information

NCT ID

NCT03385291

First Posted

October 24, 2017

Last Updated

March 7, 2018

Sponsor

First Affiliated Hospital of Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03385291

Brief Title

Effects of Different Stimuli in Patients With Disorders of Consciousness

Official Title

Effects of Acoustic Stimuli in Patients With Disorders of Consciousness: An Electroencephalography and Neuroimaging Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2015 (Actual)

Primary Completion Date

May 30, 2017 (Actual)

Study Completion Date

July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

In recent years, promoting wakening attempts in patients with disorders of consciousness are increasing, but there are a lack of objective indicators to evaluate the efficacy and further researches on the brain mechanism during the wakening processing. So, the study first assessed the cerebral response during emotional acoustic stimuli with quantitative EEG and ERP(Event-related potential), and next, the investigators explored the relationship between brain activation and patients' recovery.

Detailed Description

Auditory stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (DOC)，especially the emotional sound; 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 three acoustic stimuli using quantitative electroencephalography (QEEG) and ERP(Event-related potential),and further investigated the predictive value of QEEG in the prognosis of DOC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disorder of Consciousness

Keywords

EEG;DOC;auditory

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patients with disorders of consciousness

Arm Type

Experimental

Arm Description

3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.

Arm Title

healthy control group

Arm Type

Experimental

Arm Description

3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.

Intervention Type

Device

Intervention Name(s)

music,name,and noise sound

Intervention Description

A 5-minute baseline silence was followed by the presentation of three contrasting auditory stimuli(music,name,and noise), with a 2-minute washout silence separating each stimulus

Primary Outcome Measure Information:

Title

Glasgow Outcome Scale (GOS)

Description

A GOS value of <3 was considered as a bad recovery, while a GOS value of ≥3 was considered as a good recovery

Time Frame

In one year

Secondary Outcome Measure Information:

Title

quantitative electroencephalography

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

N1,P300,LPP

Description

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.

Time Frame

From 200 msec before the stimuli onset to 1000ms after the auditory stimulation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Brain-damaged patients : Inclusion Criteria: 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. Exclusion Criteria: hearing Problem Uncontrolled Epilepsy Autonomic crises Medical unstable state Pregnant or likely to be (interrogation data) or breastfeeding woman Healthy participants : Inclusion Criteria: Subjects with normal hearing Absence of neurological disorder Subjects able to understand the experimental instructions Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benyan Luo

Organizational Affiliation

The First Affiliated Hospital, Zhejiang University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30233062

Citation

Wu M, Bao WX, Zhang J, Hu YF, Gao J, Luo BY. Effect of acoustic stimuli in patients with disorders of consciousness: a quantitative electroencephalography study. Neural Regen Res. 2018 Nov;13(11):1900-1906. doi: 10.4103/1673-5374.238622.

Results Reference

derived

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Effects of Different Stimuli in Patients With Disorders of Consciousness

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