NCT03385291

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
Last Updated

March 8, 2018

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

October 24, 2017

Last Update Submit

March 7, 2018

Conditions

Disorder of Consciousness

Keywords

EEG;DOC;auditory

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • quantitative electroencephalography

    30 minutes before the auditory stimualtion and 30 minutes after each stimulation

Other Outcomes (1)

  • N1,P300,LPP

    From 200 msec before the stimuli onset to 1000ms after the auditory stimulation

Study Arms (2)

patients with disorders of consciousness

EXPERIMENTAL

3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.

Device: music,name,and noise sound

healthy control group

EXPERIMENTAL

3 minutes stimulation with music,name,and noise separately,each are separated with a 5 minutes washout period.

Device: music,name,and noise sound

Interventions

music,name,and noise soundDEVICE

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

healthy control grouppatients with disorders of consciousness

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • hearing Problem
  • Uncontrolled Epilepsy
  • Autonomic crises
  • Medical unstable state
  • Pregnant or likely to be (interrogation data) or breastfeeding woman
  • Healthy participants :
  • Subjects with normal hearing
  • Absence of neurological disorder
  • Subjects able to understand the experimental instructions
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30233062DERIVED

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Benyan Luo

    The First Affiliated Hospital, Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

December 28, 2017

Study Start

July 1, 2015

Primary Completion

May 30, 2017

Study Completion

July 30, 2017

Last Updated

March 8, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share