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Effects of Different Stimuli in Patients With Disorders of Consciousness

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ClinicalTrials.gov Identifier: NCT03385291
Recruitment Status : Completed
First Posted : December 28, 2017
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

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.

Condition or disease Intervention/treatment Phase
Disorder of Consciousness Device: music,name,and noise sound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Acoustic Stimuli in Patients With Disorders of Consciousness: An Electroencephalography and Neuroimaging Study
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : July 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
Experimental: patients with disorders of consciousness
3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.
Device: music,name,and noise sound
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

Experimental: healthy control group
3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.
Device: music,name,and noise sound
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 Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Brain-damaged 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 participants :

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385291


Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
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Principal Investigator: Benyan Luo The First Affiliated Hospital, Zhejiang University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03385291     History of Changes
Other Study ID Numbers: disorders of consciousness
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Zhejiang University:
EEG;DOC;auditory
Additional relevant MeSH terms:
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Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders