Assessment of characteristic disease signs and evaluation of a treatment approach with low-intensity electrical brain stimulation in persons with visual snow syndrome

Phase 2

• Conditions: euromodulatory treatment approach and evaluation of diagnostic marker for the Visual Snow Syndrome (a migraine related perceptual disorder).; Nervous System Diseases

• Registration Number: ISRCTN55942704
• Lead Sponsor: Insel Gruppe AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-19
• Last Update Posted: 22 May 2023
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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)

Controls:
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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified