💬In plain words
What the trial is, and whether it could suit you
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Severe consciousness disorder patients aged 18 to 75 years old, regardless of gender;
* Patients with severe consciousness disorders, namely a minimally conscious state or vegetative state that lasts for 28 days or more;
* 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;
* Written informed consent obtained from the patient's family members in advance.
Exclusion Criteria:
* Individuals with a previous history of significant neuropsychiatric and other major disorders such as those involving the heart, lung, liver, and kidney;
* Those who have undergone V-P shunt or Ommaya reservoir implantation and other procedures that may influence the analysis of magnetic resonance scanning signals;
* Patients who are scheduled for V-P shunt or Ommaya reservoir implantation in the near future;
* Pregnant women;
* Those who have participated in other drug or device clinical trials;
* Patients with poorly controlled epilepsy in the recent period;
* Those with infections at the TI stimulation site or compromised skin integrity at the electrode placement site;
* Those currently taking medications prone to inducing epilepsy, such as quinolone drugs;
* Those with intracranial infections, intracranial tumors, or metallic objects within the cranium;
* Those allergic to electrode gel or adhesives;
* Those with implanted electronic devices within the body;
* Those with severe cardiac disorders and those equipped with cardiac pacemakers.
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