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

Tracking Information

• First Submitted Date: October 24, 2017
• First Posted Date: December 28, 2017
• Last Update Posted Date: March 8, 2018
• Actual Study Start Date: July 1, 2015
• Actual Primary Completion Date: May 30, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 20, 2017)

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 7, 2018)

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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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

Study Arms

• Experimental: patients with disorders of consciousness
  3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.
  Intervention: Device: music,name,and noise sound
• Experimental: healthy control group
  3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.
  Intervention: Device: music,name,and noise sound

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 20, 2017): 28
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 30, 2017
• Actual Primary Completion Date: May 30, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03385291
• Other Study ID Numbers: disorders of consciousness
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: First Affiliated Hospital of Zhejiang University
• Original Responsible Party: Same as current
• Current Study Sponsor: First Affiliated Hospital of Zhejiang University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: First Affiliated Hospital of Zhejiang University
• Verification Date: October 2017