Phase
Condition
N/ATreatment
Personalized Miamind Neurostimulator
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are overtly healthy as determined by medical evaluation includingmedical history and physical examination.
Able and willing to provide voluntary written Informed Consent and sign the ICF toparticipate in the study prior to any study-related procedure.
Must have the ability to comply with protocol-related tests, appointments, andprocedures.
Age over 18 years old.
Knowledge of the German language (B1 or higher).
No history of intellectual or learning disability; at least 8 grades of school.
Non-disturbing hairstyle or headdress that enables electrode contact with the scalpjudged by the investigator.
Exclusion
Exclusion Criteria:
Any acute or chronic disease/disorder (e.g., cerebral, psychiatric, cardiovascular,pulmonary, metabolic, skin etc.)
History of traumatic brain injury or other diseases of the central nervous system.
History of seizures, diagnosis of epilepsy, or abnormal (epileptiform) EEG, orimmediate (1st-degree relative) family history of epilepsy.
Diagnosis of substance abuse.
Participant is under the influence of alcohol, and consumption of narcotics orbenzodiazepines, or other sleeping medications prior to the procedure.
All female participants that are not post-menopausal (defined as at least 12 monthsof spontaneous amenorrhea in women over 45 years old) or surgically sterile (e.g.bilateral tubal ligation, hysterectomy, bilateral oophorectomy) will be required tohave a pregnancy test; any participant who is pregnant or breastfeeding will not beenrolled in the study.
Metal implants (excluding dental fillings) or devices such as a pacemaker,cardioverter defibrillator, medication pump, nerve stimulator, TranscutaneousElectrical Nerve Stimulator (TENS) unit, ventriculoperitoneal shunt, and cochlearimplant, unless cleared by the study MD.
Contraindications for undergoing MRI.
Ongoing participation in any other interventional clinical study with aninvestigational drug or another MD within the 30 days preceding and during thepresent investigation.
Participants not suitable for the study based on a holistic consideration of theparticipant's history and the PI's medical expertise.
No vulnerable subject is enrolled on this study
Study Design
Study Description
Connect with a study center
Universitätsspital Basel
Basel, Basel-Stadt 4031
SwitzerlandSite Not Available
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