Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Zurich
With
University Hospital, Zürich
Swiss MS Society
Data Management, Clinical Trials Center, Zurich, Switzerland
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Informed Consent as documented by signature
Participants are capable of giving informed consent
Participant who have a good knowledge of German (patient information and consent must be understood)
Patients, presenting with typical signs and symptoms suggestive of a first-ever episode of unilateral acute autoimmune, inflammatory, demyelinating ON, including idiopathic ON and ON suggestive of multiple sclerosis (MS) (typical clinically isolated syndrome, or with an established diagnosis of relapsing-remitting MS according to latest panel criteria and no better explanation)
Patients with high-contrast visual acuity of ≤ 0.63 (decimal system) corresponding to a LogMAR value of ≥ 0.2 on the affected eye (assessed using a Snellen chart during clinical routine)
Patients presenting in clinics within 14 days of symptom onset
In principle 18-50 year old female and male patients may be recruited. However, since the randomization of patients will be controlled for gender and participants will be enrolled one at a time on a continuous basis, the gender might become relevant late in the study (e.g. if the female block has already been fully recruited and only males might still be enrolled).
Patients are receiving standard-of-care treatment for ON (cortisone therapy)
You may not be if
Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
Patients with a previous clinical history of ON in the respective eye
Patients with obvious retinal pathology other than that associated with ON
Patients who are unable to perform the study assessments (e.g. OCT examination) because of a severe nystagmus (repetitive, uncontrolled eye movements causing unsteady fixation)
Patients with a recent eye surgery
Patients with known anti-aquaporin-4- or myelin oligodendrocyte glycoprotein- antibody seropositivity
Patients with contraindications to the class of device under study (for rtACS): implanted electronic devices, metallic artefacts in the head (excluding dentition), epilepsy, brain cancer, pregnancy, breastfeeding, increased intraocular pressure without appropriate treatment, arterial hypertension without appropriate treatment, skin irritations at intended positions of electrodes, cognitive deficits (unable to provide written informed consent or follow the instructions)
Known or suspected non-compliance, drug or alcohol abuse
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Participation in another study with investigational drug/device within the 30 days preceding and during the present study
Previous enrolment into the current study
Enrolment of the investigator, his/her family members, employees and other dependent persons
