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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
8
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).
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Safety: Incidence of Treatment-Emergent Adverse Events
Safety of the Treatment defined as the proportion of study participants free of serious adverse device effects and unanticipated serious adverse device effects (SADE and USADE) assessed via a safety questionnaire and medical evaluation.
Time frame: up to 2 weeks
Safety and comfort: questionnaire
Adverse Events and comfort of tACS and the medical device are reported by questionnaires following stimulation of each target region at visit °3 \& °4 and following sequential stimulation of multiple target regions at visit °5 \& °6.
Time frame: up to 2 weeks
Evaluation of functional impact of tACS on Attention and Concentration: d2-R attention test
Changes in d2-R attention test are reported to document the functional impact of tACS on concentration and attention before and after stimulation of each target region at visit °3 \& °4 and before and after sequential stimulation of multiple target regions at visit °5 \& °6. The d2-R attention test measures processing speed, rule compliance, and quality of performance as estimation of attention and concentration and scores them as the following separate items: speed, concentration, carefulness. Each item is scored from 20-80. A higher score indicates better performance.
Time frame: up to 2 weeks
Evaluation of functional impact of tACS on oscillatory activity: Electroencephalography (EEG)
Quantification of EEG measurements to document the functional impact of tACS on oscillatory activity in individual frequency bands (delta, theta, alpha, beta, gamma) and EEG-biomarkers (alpha peak frequency, Vigilance) before and after stimulation of each target region at visit °3 \& °4 \& °5 \& °6.
Time frame: up to 2 weeks
Cognitive Evaluation: Montreal Cognitive Assessment (MoCA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MoCA scores are documented before and after visit °3 and after visit °6 to evaluate the impact of repeated tACS on cognitive performance. The MoCA has a total scoring range of 0-30, with the score based on the number of correct answers made in each of the 7 following items: Visuospatial/Executive, Naming, Memory/delayed recall, Attention, Language, Abstraction, Orientation. Sub-scores and total score are reported. A lower total score indicate greater cognitive impairment.
Time frame: up to 2 weeks
Participant coherence and satisfaction questionnaire
The subjective impression and satisfaction of the participant regarding the device and the intervention is documented using a one-time questionnaire at the end of the study.
Time frame: up to 2 weeks