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Completed

NCT Number: NCT03385291

Effects of Different Stimuli in Patients With Disorders of Consciousness

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.

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Key information

Conditions

Disorder of Consciousness Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

music,name,and noise sound

Device

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 outcomes

  1. Glasgow Outcome Scale (GOS)

    Time frame: In one year

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

Secondary outcomes

  1. quantitative electroencephalography

    Time frame: 30 minutes before the auditory stimualtion and 30 minutes after each stimulation

    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.

Other outcomes

  1. N1,P300,LPP

    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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2017
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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