Disorders of Consciousness
Conditions
Interventions
Temporal Interference Stimulation group:Temporal Interference Stimulation
Sham Temporal Interference Stimulation group:Sham Temporal Interference Stimulation
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Severe consciousness disorder patients aged 18 to 65 years old, regardless of gender; 2. Patients with severe consciousness disorders, namely a minimally conscious state or vegetative state that lasts for 28 days or more; 3. Patients with normal body temperature, stable vital signs, spontaneous breathing, tracheotomy without the use of a metal cannula and with a small amount of sputum, and who are eligible for magnetic resonance imaging (MRI) examination; 4. Written informed consent obtained from the patient's family members in advance.
Exclusion criteria
Exclusion criteria: 1. Individuals with a previous history of significant neuropsychiatric and other major disorders such as those involving the heart, lung, liver, and kidney; 2. Those who have undergone V-P shunt or Ommaya reservoir implantation and other procedures that may influence the analysis of magnetic resonance scanning signals; 3. Patients who are scheduled for V-P shunt or Ommaya reservoir implantation in the near future; 4. Pregnant women; 5. Those who have participated in other drug or device clinical trials; 6. Patients with poorly controlled epilepsy in the recent period; 7. Those with infections at the TI stimulation site or compromised skin integrity at the electrode placement site; 8. Those currently taking medications prone to inducing epilepsy, such as quinolone drugs; 9. Those with intracranial infections, intracranial tumors, or metallic objects within the cranium; 10. Those allergic to electrode gel or adhesives; 11. Those with implanted electronic devices within the body; 12. Those with severe cardiac disorders and those equipped with cardiac pacemakers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of awakening; | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavioral improvement;Behavioral improvement;Behavioral improvement;Behavioral improvement;Behavioral improvement;Security indicators; | — |
Countries
China
Contacts
Public ContactXuehai Wu
Huashan Hospital, Fudan University
Outcome results
None listed