NCT05999916

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Bottneuro AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Participants
• Healthy Population

Interventions

Type	Name	Description
DEVICE	Personalized Miamind Neurostimulator	60 min. 40 Hz max. 1mA / electrode \& total of max. 2 mA across all electrodes. 30- s ramp-up personalised intervention based on individual modelling of electric field distribution to maximise therapeutic effect in the target region. Three target regions, consecutively stimulated (20min each).

Timeline

• Start date: 2023-12-27
• Primary completion: 2024-03-22
• Completion: 2024-03-22
• First posted: 2023-08-21
• Last updated: 2024-08-06

Locations

1 site across 1 country: Switzerland