Prolonged disorders of consciousness
Conditions
Interventions
taVNS group:Patients in the taVNS group will be treated with taVNS plus conventional therapy. An electrical stimulator (tVNS501, Changzhou Rishena Medical Device Co., Ltd., Jiangsu, China) will be app
Control group:Patients in the control groups will receive a taVNS placebo procedure in addition to conventional therapy. For the taVNS placebo, the stimulator will offer a built-in placebo mode: upon
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Diagnosed as VS/UWS or MCS with CRS-R; 3. With onset of disease at least 28 days and less than 1 year before enrollment; 4. Informed consent given by legal guardian.
Exclusion criteria
Exclusion criteria: 1. Anyone who has local lesions, rash and infection at the left cymba conchae; 2. With heart rate less than 60 beats/min; 3. History of implanted excitatory device (e.g., pacemaker, implanted vagus nerve electrical stimulator, deep brain electrical stimulator, electrical spinal cord stimulator…); 4. Deep sedation condition caused by general anaesthetics or sedatives (e.g., propofol, benzodiazepines); 5. Complications such as acute myocardial infarction, pulmonary embolism, acute infection, sepsis, severe anemia or other clinical critical condition; 6. Participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of improved consciousness level at weeks 4 after trial initiation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Coma Recovery Scale-Revised total scores and subscale scores;Glasgow Coma Scale total scores and subscale scores;Full Outline of UnResponsiveness Scale total scores and subscale scores;Electrocardiogram parameters;brainstem auditory evoked potential;Upper-limb somatosensory evoked potential;Neuroimaging parameters based on positron emission tomography/functional magnetic resonance imaging ;Serum biomarkers associated with conscious levels;Adverse events; | — |
Countries
China
Contacts
Public ContactLu Xiao
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed