Long-term impaired consciousness
Conditions
Interventions
tTIS group:tTIS and regular treatment
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old; 2. Patients who are clinically diagnosed with vegetative state or microconscious state by CRS-R scale score; 3. The course of the disease >=28 days but < 1 year; 4. The cause is severe acquired brain injury; 5. The patient's legal guardian signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with internal implants incompatible with MRI scanning systems; 2. Patients in deep sedation; 3. Patients with a history of severe central nervous system developmental abnormalities, severe neurologic or psychiatric disorders or substance use, e.g., mental retardation, prior severe craniocerebral injury, epilepsy; 4. Patients with a documented seizure within the last 1 month after insult; 5. pregnant women; 6. Patients with organ dysfunction; 7. Patients with hyperthermia; 8. Patients with infection; 9. Patients with uncontrolled severe hypertension or other major complications; 10. Patients with acute myocardial infarction; 11. Patients with acute pulmonary embolism; 12. Patients with deep vein thrombosis; 13. Patients with other clinically critical states such as severe anaemia; 14. Patients with concurrent participation in other clinical trials; 15. Patients at high risk of high risk but with low benefit from the tTIS intervention, assessed by the principal investigator (PI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coma Recovery Scale-Revised;AE, SAE;Glasgow Coma Scale;Full Outline of UnResponsiveness;Glasgow Outcome Scale-Extended;Disability Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| EEG and fMRI; | — |
Countries
China
Contacts
Public ContactXiao Lu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed