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

Last updated: August 5, 2024
Sponsor: Bottneuro AG
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Personalized Miamind Neurostimulator

Clinical Study ID

NCT05999916
BTN-100
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants who are overtly healthy as determined by medical evaluation includingmedical history and physical examination.

  2. Able and willing to provide voluntary written Informed Consent and sign the ICF toparticipate in the study prior to any study-related procedure.

  3. Must have the ability to comply with protocol-related tests, appointments, andprocedures.

  4. Age over 18 years old.

  5. Knowledge of the German language (B1 or higher).

  6. No history of intellectual or learning disability; at least 8 grades of school.

  7. Non-disturbing hairstyle or headdress that enables electrode contact with the scalpjudged by the investigator.

Exclusion

Exclusion Criteria:

  1. Any acute or chronic disease/disorder (e.g., cerebral, psychiatric, cardiovascular,pulmonary, metabolic, skin etc.)

  2. History of traumatic brain injury or other diseases of the central nervous system.

  3. History of seizures, diagnosis of epilepsy, or abnormal (epileptiform) EEG, orimmediate (1st-degree relative) family history of epilepsy.

  4. Diagnosis of substance abuse.

  5. Participant is under the influence of alcohol, and consumption of narcotics orbenzodiazepines, or other sleeping medications prior to the procedure.

  6. 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.

  7. 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.

  8. Contraindications for undergoing MRI.

  9. Ongoing participation in any other interventional clinical study with aninvestigational drug or another MD within the 30 days preceding and during thepresent investigation.

  10. 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

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Personalized Miamind Neurostimulator
Phase:
Study Start date:
December 27, 2023
Estimated Completion Date:
March 22, 2024

Study Description

The pathological hallmarks of Alzheimer's Disease (AD) are extracellular amyloid-β (Aβ) plaques and intracellular neurofibrillary tangles of hyperphosphorylated tau deposition in the brain together with neuroinflammation and microglial activation. These alterations lead to synaptic dysfunction, neuronal loss, and subsequently to brain circuit and brain oscillation disruption, resulting in cognitive decline. Recent studies have shown a positive effect of neural entrainment at gamma frequency (30-80 Hz). Transcranial alternating current stimulation (tACS) utilizes low amplitude alternating currents, allowing for frequency and region-specific brain oscillation entrainment showing positive results regarding improvement of cognitive functions in healthy participants and Alzheimer's Disease patients. Miamind Neurostimulator is a patient specific MRI-based 3D printed medical device that permits electrical stimulation and recording on up to 32 electrode channels and thus allows for simultaneous, multifocal, and targeted brain stimulation. tACS is non- invasive, well tolerated by users and considered safe with no persistent adverse events reported.

Connect with a study center

  • Universitätsspital Basel

    Basel, Basel-Stadt 4031
    Switzerland

    Site Not Available

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