Evaluate the Safety and Feasibility of tACS With the Miamind Neurostimulator in Healthy Participants

Korábbi kezelés

• Participant is under the influence of alcohol, and consumption of narcotics or benzodiazepines, or other sleeping medications prior to the procedure.
• Metal implants (excluding dental fillings) or devices such as a pacemaker, cardioverter defibrillator, medication pump, nerve stimulator, Transcutaneous Electrical Nerve Stimulator (TENS) unit, ventriculoperitoneal shunt, and cochlear implant, unless cleared by the study MD.
• Ongoing participation in any other interventional clinical study with an investigational drug or another MD within the 30 days preceding and during the present investigation.

Más betegség

• 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, or immediate (1st-degree relative) family history of epilepsy.

Életkor

• All female participants that are not post-menopausal (defined as at least 12 months of spontaneous amenorrhea in women over 45 years old) or surgically sterile (e.g. bilateral tubal ligation, hysterectomy, bilateral oophorectomy) will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study.

Egyéb

• Diagnosis of substance abuse.
• Contraindications for undergoing MRI.
• Participants not suitable for the study based on a holistic consideration of the participant's history and the PI's medical expertise.
  • No vulnerable subject is enrolled on this study

• Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
• Able and willing to provide voluntary written Informed Consent and sign the ICF to participate in the study prior to any study-related procedure.
• Must have the ability to comply with protocol-related tests, appointments, and procedures.
• 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 scalp judged by the investigator.