Effects of Different Stimuli in Patients With Disorders of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385291
• Other study ID #: disorders of consciousness
• Status: Completed
• Phase: N/A
• First received: October 24, 2017
• Last updated: March 7, 2018
• Start date: July 1, 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: October 2017
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disease
• Disorder of Consciousness

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	N1,P300,LPP	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.	From 200 msec before the stimuli onset to 1000ms after the auditory stimulation
Primary	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	In one year
Secondary	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 a and ß is related to the chance of recovery.	30 minutes before the auditory stimualtion and 30 minutes after each stimulation