Consciousness Disorder Clinical Trial
Official title:
Prognosis of Acute DOC
Prior research has indicated a link between outcomes in patients with disorders of consciousness (DOC) and their responses to emotional auditory stimuli. Given the high degree of uncertainty in acute situations, this study plans to record EEG responses and observe microexpressions in DOC patients during exposure to auditory stimuli, with the aim to identify more reliable prognostic indicators. The goal is to uncover potential patterns or signals that can contribute to a more comprehensive understanding of a patient's condition, and thereby provide more accurate prognostication.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients with acute brain injury (<28 days) in ICU - GCS = 8 - = 2 days after sedation - Normal hearing, with auditory startle reflex Exclusion Criteria: • Children under 18 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glasgow Outcome Scale-Extended (GOS-E) | GOS-E is an extended version of the Glasgow Outcome Scale (GOS), which was developed to provide a more detailed assessment of patient functionality and quality of life after experiencing such an injury. It has eight categories: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery. | Month 1 | |
Primary | Glasgow Outcome Scale-Extended (GOS-E) | GOSE will be assessed 3 months after brain injury. | Month 3 | |
Primary | Glasgow Outcome Scale-Extended (GOS-E) | GOSE will be assessed 6 months after brain injury. | Month 6 | |
Primary | Glasgow Outcome Scale-Extended (GOS-E) | GOSE will be assessed 12 months after brain injury. | Month 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04534777 -
Multimodal Neuroprognostication in Disorders of Consciousness
|
||
Completed |
NCT03504709 -
REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness
|
||
Recruiting |
NCT05823454 -
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness
|
||
Recruiting |
NCT04978857 -
Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
|
N/A | |
Not yet recruiting |
NCT05670873 -
Transcranial Magnetic Stimulation in Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients
|
N/A | |
Terminated |
NCT03023657 -
Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient
|
N/A | |
Completed |
NCT04435301 -
Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness
|
N/A | |
Completed |
NCT05802524 -
Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness
|
||
Not yet recruiting |
NCT04248946 -
Neural, Behavioural, and Clinical Effects of tDCS in PDOC; Feasibility Study
|
N/A | |
Completed |
NCT04476589 -
Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
|
||
Completed |
NCT04687397 -
Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)
|
||
Recruiting |
NCT04065386 -
Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness
|
N/A | |
Completed |
NCT05367999 -
A Clinical Decision Aid for Diagnosing Transient Loss of Consciousness
|
||
Completed |
NCT03341325 -
Neurovascular Reactions to AAT in Patients With DOC
|
N/A | |
Withdrawn |
NCT03475537 -
tDCS in Patients With Disorders of Consciousness
|
N/A |