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NCT05999916Completed

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

A Prospective, Single-Arm, Monocentric Pilot Study to Evaluate the Safety and Feasibility of Transcranial Alternate Current Stimulation With the Miamind Neurostimulator in Healthy Participants

Source: ClinicalTrials.gov · Last updated 6 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
8 (actual)
First submitted
3 Aug 2023
Start date
27 Dec 2023
Primary completion date
22 Mar 2024
Lead sponsor
Bottneuro AG
NCT number
NCT05999916

What you commit to

  • Study type: Interventional
  • Participants enrolled: 8
  • From 27 Dec 2023 to the primary completion date, 22 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Age

  • 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.

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitätsspital Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.