ISRCTN55942704进行中（未招募）2 期
Diagnostic markers and neuromodulatory treatment approach with transcranial alternating current stimulation (tACS) for visual snow syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 13/04/2023:
- •Subjects with VSS:
- •1. Informed consent signed
- •2. Subjects with VSS should fulfill the criteria of the International Headache Society (ICDH 3, A1.4.6)
- •1. Informed consent signed
- •2. Matched to the subjects with VSS (sex, age and migraine)
- •Previous inclusion criteria:
- •1. Informed consent signed
- •2. Subjects with VSS should fulfil the criteria of the International Headache Society (ICDH 3, A1.4.6)
排除标准
- •Current exclusion criteria as of 13/04/2023:
- •Subjects with VSS:
- •1. Contraindications and limitations of the MD as described in the instructions for use: implanted electrical devices, cranial implants (like metal plates or screws), skull defects or head injuries
- •2. Contraindications to the class of MD under investigation, e.g. known hypersensitivity or allergy to the device material (rubber or sponge materials)
- •3. Pregnancy
- •4. Skin diseases with lesions on the scalp
- •5. Persons who are less than 18 years old
- •All subjects:
- •6. Clinically significant concomitant disease states (like epilepsy, brain tumors, traumatic, infectious or metabolic lesions or diseases of the brain, sleep disorders)
- •7. Known or suspected non-compliance
- •8. Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc., of the subject
- •9. Participation in another investigation with an investigational drug or another medical device within the 30 days preceding and during the present investigation
- •10. Enrolment of the PI, their family members, employees and other dependent persons
- •11. Auditory and visual (if not correctable with glasses) impairment
- •12. Pharmaceutical treatment for conditions related to the central nervous system
- •13. Therapeutic treatment which change the excitability of the central nervous system
- •14. Illicit substances or other substances that modify a person’s natural perception regardless of whether those are commonly understood as therapeutic drugs
- •Previous exclusion criteria:
- •1. Implanted electrical devices, cranial implants (like metal plates) or screws, skull defects or head injuries
- •2. Allergy to the device material
- •3. Clinically significant concomitant disease states (e.g., bipolar disorder, schizophrenia, epilepsy and structural cerebral lesions and other conditions when the investigator thinks it may not be safe to include a specific patient)
- •4. Vulnerable subjects
- •5. Known or suspected non-compliance, drug or alcohol abuse,
- •6. Inability to follow the procedures of the investigation
- •7. Skin diseases with lesions on the scalp
- •8. Auditory or visual impairment
研究者
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