Effects of Different Stimuli in Patients With Disorders of Consciousness

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

• Principal Investigator: Benyan Luo; The First Affiliated Hospital, Zhejiang University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: First Affiliated Hospital of Zhejiang University
• ClinicalTrials.gov Identifier: NCT03385291
• Other Study ID Numbers: disorders of consciousness
• First Posted: December 28, 2017
• Last Update Posted: March 8, 2018
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders