Evaluate the Safety and Feasibility of tACS With the Miamind Neurostimulator in Healthy Participants (NCT05999916) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Safety and Feasibility of tACS With the Miamind Neurostimulator in Healthy Participants
Switzerland8 participantsStarted 2023-12-27
Plain-language summary
The present study aims to assess the safety and feasibility of repeated transcranial alternating current stimulation (tACS) by the Miamind Neurostimulator in a cohort of healthy participants. Based on the findings of this investigation, subsequent clinical trials assessing the efficiency of tACS by the Miamind Neurostimulator for treatment of Alzheimer's Disease will be conducted.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
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, or immediate (1st-degree relative) family history of epilepsy.
✕. Diagnosis of substance abuse.
✕. Participant is under the influence of alcohol, and consumption of narcotics or benzodiazepines, or other sleeping medications prior to the procedure.
What they're measuring
1
Safety: Incidence of Treatment-Emergent Adverse Events
✕. 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.
✕. 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.