prolonged disorders of consciousness (pDoC)
Conditions
Interventions
Experimental group:2-week TIS stimulation (20 minutes/time, 2 times/day, 5 days/week, a total of 10 times) combined with conventional rehabilitation therapy
Sponsors
West China hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. According to the Expert Consensus on Naming and Classification of Chronic Mental Disorders [13], it meets the diagnostic criteria of VS/UWS or MCS; 2. Acquired brain injury (such as traumatic brain injury, stroke, hypoxic-ischemic encephalopathy, etc.), and within 4 weeks to 12 months of the onset of consciousness disorders; 3. Vital signs and clinical conditions remain stable for at least one week; 4. Age between 18-70 years old; 5. Sign the informed consent form by the legal representative; 6. Prior to enrollment, an MRI examination can be performed to accurately locate the lesion site.
Exclusion criteria
Exclusion criteria: 1. Contraindications for TIS (such as implantation of pacemakers, metal brain implants, or drug-resistant epilepsy); 2. Serious uncontrolled systemic diseases (such as severe heart failure, liver and kidney failure, etc.); 3. Untreated intracranial aneurysms, severe hydrocephalus or extensive brain softening lesions, and active intracranial hypertension; 4. Skull defects in the dorsolateral prefrontal or parietal regions, making it impossible to place electrodes for localization; 5. Use sedatives, sodium calcium channel blockers (such as carbamazepine), or N-methyl-D-aspartate receptor antagonists (such as dexmedetomidine) that may significantly affect consciousness levels or brain excitability; 6. Previous presence of neurodegenerative diseases; 7. Unable to tolerate fMRI, EEG, fNIRS, TMS-EEG, ERP and other examinations, or have contraindications for related examinations; 8. Currently participating in other interventional clinical trials that may interfere with the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Coma Recovery Scale-Revised, CRS-R;Glasgow Coma Scale, GCS;electroencephalography, EEG;Resting-state Functional Magnetic Resonance Imaging,rest-fMRI;functional near - infrared spectroscopy,?fNIRS;transcranial magnetic stimulation - electroencephalography, TMS-EEG;event-related brain potential, ERP; | — |
Countries
China
Contacts
Public ContactCheng Huang
West China Hospital, Sichuan University
Outcome results
None listed