Cranial brain injury
Conditions
Interventions
TI Group:Time-Interfered Stimulation
Sham-TI Group:Placebo Stimulation
Sponsors
Shandong Provincial Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Have a clear history of craniocerebral injury or ischemic/hemorrhagic stroke, with post-injury disorders of consciousness, including coma, vegetative state (VS) or minimally conscious state (MCS), and a clear diagnosis of parenchymal cerebral injury, brainstem injury, diffuse axonal injury, etc., accompanied by clinical signs of disorders of consciousness (e.g., changes in bilateral pupils, unresponsiveness to painful stimuli), after cranial CT or MRI examination; 2. Age between 18 and 70 years old, male or female; 3. The duration of the disorder of consciousness is between 1 and 12 months, and it is in the subacute or chronic stage; 4. Vital signs are stable after stabilisation, survival > 72 hours, and postoperative observation of surgical patients reaches 72 hours with no active intracranial haemorrhage on imaging; 5. CRS-R score >= 8 and duration of coma >= 6 hours, or re-deterioration of consciousness within 24 hours after injury and continued coma >= 6 hours; 6. Currently an inpatient of the Department of Critical Care Rehabilitation of our hospital, with complete medical records, able to cooperate with the study observation records; 7. The patient's family members agreed to the study and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe systemic conditions such as combined cardiopulmonary insufficiency, malignant tumours, or significant hepatic or renal impairment who cannot tolerate MRI examinations or electrical stimulation therapy; 2. Patients with active intracranial haemorrhage, space-occupying lesions, or acute intracranial hypertension posing a life-threatening risk; 3. Cranial defect area exceeding 5 cm² or absence of cranial repair; 4. History of severe psychiatric disorders or active epileptic seizures; 5. Presence of implanted metallic devices (e.g., cardiac pacemakers, cochlear implants, metallic cranial clips); 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRS-R; | — |
Secondary
| Measure | Time frame |
|---|---|
| fMRI;Glasgow Coma Scale;GOS-E; | — |
Countries
China
Contacts
Public ContactLuwei
Shandong Provincial Third Hospital
Outcome results
None listed