Improvement of synaptic plasticity and cognitive function in RAS pathway disorders

Technische Universität München, Fakultät für Medizin0 个研究点目标入组 30 人2017年11月9日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Technische Universität München, Fakultät für Medizin
入组人数: 30
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2017年11月9日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Technische Universität München, Fakultät für Medizin

入排标准

入选标准

•1\.1\.Group 1: NS, Group 2: NF1 (both genetically assured)
•2\.Age \=16 years
•3\.The adolescent (\=16\) and legal guardian who are capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
•4\.Signed informed consent if \= 16 years and legal guardian.
•5\.Persons who are \= 18 years old and capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
•6\.Signed informed consent if \= 18 years.
•7\.Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.
•This includes:
•\-A woman who is not capable of bearing a child is defined as follows: post\-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum\-FSH\-values (follicle\-stimulating hormone) of \>40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation
•\-A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.

排除标准

•1\.Epilepsy
•2\.Medication with known CNS effects
•3\.Severe mental retardation
•4\.Side effects during previous medication with and contraindications to LTG and/or LOV and/or TMS
•5\.Psychiatric diseases
•6\.Previous history of allergic reactions with LTG and LOV medications
•7\.Potentially unreliable patients
•8\.Patients who are not suitable for the study in the opinion of the investigator
•9\.Pregnancy (incl. positive urine pregnancy test)
•10\.Persons who are incapable of giving consent or do not understand the aim or rationale of the study.