DRKS00023814招募中未知
eurorehabilitation by EEG-Controlled Magnetic Stimulation
Institute of Medical Psychology and Behavioral Neurobiology. University of Tübingen0 个研究点目标入组 12 人开始时间: 2020年12月30日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Healthy participants
- •1. Subject is aged between 18 and 60 years
- •2. Subject is in good physical and mental health.
- •3. Subject understands the study procedures and risks, and agrees to participate
- •in the study by giving written informed consent
- •4. Subject is willing to comply with the study restrictions
- •Stroke patients
- •1.Subject is aged between 18 and 80 years
- •2.Subject understands the study procedures and agrees to participate in the study by giving written informed consent
- •3.Subject is willing to comply with the study restrictions
- •4.Subject had an ischemic or hemorrhagic apoplexy with a subcortical lesion (Marklager, capsula interna, pedunculi cerebri)
- •5.Subject has a substantial motoric deficit. (Medical Research Council Score of less than 2)
- •6.Subject has realistic expectations of the personal gain in mobility through the participation in this study.
- •7.Subject has the means and intentions to stay available for inventions over the course of the study.
- •8.Paralysis of one leg
- •9.Time since stroke of at least 6 months (chronic stage)
- •10.Subject has no additional diseases such as tumors, severe cardiac insufficiency or cardiac arrhythmia
- •11.Subject has no psychiatric or neurological condition other than stroke
- •12.Subject has no depression
- •13.Subject is not pregnant
- •14.Subject has no epilepsy or medication for epilepsy during the last 6 months
- •15.Subject has no metallic implants in the body
- •16.Subject did not receive Botox treatment during the last 3 months
- •17.Subject is able to understand and follow instructions
排除标准
- •Healthy participants
- •1. Subject is under the age of legal consent.
- •2. Subject is mentally or legally incapacitated, has significant emotional
- •problems or has a history of a clinically significant psychiatric disorder over
- •the last 5 to 10 years.
- •3. Subject is suffering a severe internistic, neurological or psychiatric disorder.
- •4. Subject has a history of any illness that, in the opinion of the study
- •investigator, might confound the results of the study or poses an additional
- •risk to the subject by their participation in the study.
- •6. Subject has a history of stroke, seizures, or major neurological disorder.
- •7. Subject has a history of significant head injury/trauma
- •8. Subject has a family history of epilepsy.
- •9. Subject has a cardiac pacemaker, implanted medication pump, intracardiac
- •line, or acute, unstable cardiac disease.
- •10.Subject has an intracranial implant (e.g., aneurysm clips, shunts, stimulators,
- •cochlear implants, or electrodes) or any other metal object within or near the
- •head (excluding the mouth) that cannot be safely removed.
- •Stroke patients
- •1. Subject is under the age of legal consent
- •2. Subject is mentally or legally incapacitated, has significant emotional problems or has a history of a clinically significant psychiatric disorder (including poststroke depression) over the last 5 to 10 years. Subjects who have had a stroke-unrelated situational depression may be enrolled in the study at the discretion of the investigator.
- •3. Subject has significant and uncontrollable medical conditions (severe coronal disorders, cardiac insufficiency (NYHA Degree IIIIV), severe arrhythmia, edema of high degree, malign tumors or terminal kidney failure.
- •4. Subject has a lesion in the cerebellum.
- •6. Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- •7. Subject has a family history of epilepsy.
- •8. Subject has a cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstable cardiac disease.
- •9. Subject has an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.
- •10.Subject consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.
- •11.Subject is currently a regular user (including recreational use”) of any illicit drugs or has a history of drug (including alcohol) abuse.
- •12.Subject has participated in another clinical trial within 4 weeks prior to the first study visit.
- •13.There is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason; the investigator considers the subject inappropriate for participation in the study.
研究者
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