ISRCTN66692567进行中（未招募）不适用
Functional and metabolic characterisation using 7T neuroimaging in visual snow syndrome and migraine (FOCUS-VSM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •Group 1: VSS patients
- •Diagnosis of visual snow syndrome following the published criteria
- •Aged >18 years
- •Able to provide written informed consent in English
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial detailed in the patient information sheet, informed consent form, and in the protocol
- •Willing and able to comply with scheduled visits, lifestyle guidelines and trial procedures, including using a reliable method of birth control whilst on the medication for female participants
- •No history of worsening of VSS with prior medications
- •Group 2: Migraine patients
- •Diagnosis of migraine with or without aura following the International Classification of Headache Disorders (ICHD-3) beta criteria
- •Aged >18 years
- •Able to provide written informed consent in English
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial detailed in the patient information sheet, informed consent form, and in the protocol
- •Willing and able to comply with scheduled visits, lifestyle guidelines and trial procedures, including using a reliable method of birth control whilst on the medication for female participants
- •No concomitant diagnosis of VSS
- •Group 2: Healthy controls
- •Aged >18 years
- •Able to provide written informed consent in English
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial detailed in the patient information sheet, informed consent form, and in the protocol
- •Willing and able to comply with scheduled visits, lifestyle guidelines (see below) and trial procedures
- •No concomitant diagnosis of VSS or migraine
排除标准
- •Pregnancy and breastfeeding
- •Any metal implants in the head or body (except for titanium and dental work)
- •Any other medical and safety contraindications to undergo ultra-high-field MRI (e.g., large tattoos, ongoing dizziness and vertigo)
- •History of epilepsy or of prior lamotrigine use (for VSS and MO groups only)
- •History of adverse or allergic reactions to drugs (for VSS and MO groups only)
- •Family history of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) (for VSS and MO groups only)
- •Known or suspected carriers of HLA alleles associated with SJS or TEN (e.g., HLA-B15:02, HLA-A24:02, and HLA-B38:01) (for VSS and MO groups only)
- •Regular smoking of >6 cigarettes a day
- •Regular intake of medications acting on the central nervous system
- •Regular use of recreational drugs
- •History of psychosis or psychological disease either (a) requiring ongoing psychoactive drugs, or (b) that the investigator has reason to believe will either affect the patient’s neural pathways or hinder the performance of the patient regarding the ability to successfully complete the tasks required of them according to the protocol
- •Any person unable to understand written or spoken English
- •Subjects unwilling to comply with lifestyle guidelines necessary for the study
- •Subjects who are or have recently (last 30 days) been involved in any interventional clinical trial
- •Any other condition that in the opinion of the investigator would make the subject unsuitable for the study
研究者
相似试验
Unknown
1 期
张丽美老师：该研究的伦理审批文件未上传，请尽快上传并填写伦理审批日期。 评价 MT-1207 耐受性、药代动力学Ⅰa 期临床试验ChiCTR1900025054自筹经费80
已完成
1 期
一项评价 H077 缓释片在健康受试者中单次给药药代动力学及食物影响的 I 期临床研究治疗良性前列腺增生症引起的症状和体征CTR20243638上海汇伦医药股份有限公司
进行中（未招募）
1 期
HRN77 片对健康参与者影响的 I 期临床研究产后抑郁症CTR20262522湖南明瑞制药股份有限公司 / 北京华睿鼎信科技有限公司
招募中
1 期
HRN77 片对健康参与者影响的 I 期临床研究产后抑郁症CTR20262522湖南明瑞制药股份有限公司 / 北京华睿鼎信科技有限公司
尚未招募
1 期
RL001 的食物影响研究以及与原研 Zytiga 的生物利用度研究本品与泼尼松或泼尼松龙合用，治疗： 1）转移性去势抵抗性前列腺癌（mCRPC）； 2）新诊断的高危转移性内分泌治疗敏感性前列腺癌（mHSPC），包括未接受过内分泌治疗或接受内分泌治疗最长不超过 3 个月。CTR20255262湖南慧泽生物医药科技有限公司 / 江苏万高药业股份有限公司