Complexity-enhancing drugs to treat disorders of consciousness (DoC): a ketamine study - ComplEXIT-DOC_KET

niversity of Liège0 个研究点目标入组 30 人开始时间: 2022年2月11日最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•- 18-55 years old
•- Clinically stable, not dependent on medical ventilators for respiration
•- Diagnosed as an unresponsive wakefulness syndrome or a minimally conscious state according to the international criteria and based on at least 2 standardized behavioral assessments with the Simplified Evaluation of CONsciousness Disorders (SECONDs)
•- More than 28 days post-insult
•- Informed consent from a legal representative of the patient
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Use of neurological medications other than anti-spasticity drugs in the last 2 weeks or 4 half-lives of the drug
•- A history of previous neurological functional impairment other than related to their acquired brain injury
•- A history of psychiatric disorders
•- First-degree psychiatric disorder in the family
•- Contraindication to MRI, EEG, PET, or TMS (e.g., electronic implanted devices, external ventricular drain)
•- Use of nitrates or other vasodilators, central nervous system acting agents such as barbiturates, morphine and related drugs
•- Use of drugs known to interact with ketamine. Among them: thyroid hormones, diazepam, and barbiturates, drugs that interact with CYP3A4, other anesthetics like tramadol or anesthetic halogen
•- Coronary insufficiency
•- Kidney failure
•- Other sympathomimetic drugs
•- Active epilepsy
•- Use of antiepileptic medication in the previous month
•- Known allergy or hypersensitivity to ketamine

发起方

niversity of Liège