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Digital Twins for Model-driven Non-invasive Electrical Brain Stimulation
Sponsor: I.R.C.C.S. Fondazione Santa Lucia
Summary
The purpose of this study is to obtain preliminary data in advance of a larger clinical trial designed to test whether repeated, daily sessions of at-home transcranial alternating current stimulation (tACS) can lead to a clinically significant improvement in patients with AD. Given the potentially fragile patient population, the investigators propose a pilot study to test feasibility and safety (primary). In this pilot study 30 mild-to-moderate AD patients will be enrolled. The intervention will consist of daily model-optimized and individualized tES delivered for 8 weeks, 5 days per week (40 sessions). tACS will be applied daily for 1 hour and will be paired with extensive neuroimaging, neurophysiological and neuropsychological evaluation at several time points (pre and post treatment) to better characterize patients and their response to treatment. The physiological target of treatment will be to increase gamma activity in the pre-frontal cortex, as this has been associated with cognitive decline in AD, and prior tES work targeting PFC gamma oscillations has shown promising results. The investigators hypothesize that active tACS treatment will result in a comparatively slower progression of cognitive decline and loss of gamma power as compared to sham treatment. To assess this, in this pilot study, a cross-over design will be used. Treatment will be multisession since prior tES work indicates a cumulative effect of each session with stronger therapeutic effects, in line with the underlying Hebbian mechanisms putatively involved in non-invasive brain stimulation.
Official title: Home-based Transcranial Electrical Stimulation (tES) in Alzheimer's Disease
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-05-04
Completion Date
2025-06-30
Last Updated
2025-02-13
Healthy Volunteers
No
Conditions
Interventions
transcranial alternating current stimulation
The intervention employs transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique designed to modulate neural oscillations in targeted brain regions. tACS operates by applying low-intensity, alternating electrical currents through electrodes placed on the scalp, synchronizing with the brain's natural frequency patterns. In this arm, a frequency of 40 Hz (gamma frequency) is used to enhance oscillatory activity related to cognitive functions often impaired in Alzheimer's disease (AD). The Neuroelectrics Starstim-home device will be used. This compact, portable device allows for easy use within the home setting, reducing the need for daily clinic visits. Designated caregivers will administer the one-hour tACS sessions under remote supervision via a digital monitoring portal, which tracks adherence, technical performance, and safety data in real time.
sham transcranial alternating current stimulation
The intervention employs transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique designed to modulate neural oscillations in targeted brain regions. tACS operates by applying low-intensity, alternating electrical currents through electrodes placed on the scalp, synchronizing with the brain's natural frequency patterns. In this arm, the stimulation will be delivered in 'sham' mode which is characterized by 30 seconds of tACS stimulation at the beginning and end of the protocol to help with blinding. During the rest of the stimulation period (1h) no stimulation will be delivered. The Neuroelectrics Starstim-home device will be used. This compact, portable device allows for easy use within the home setting, reducing the need for daily clinic visits. Designated caregivers will administer the sham tACS sessions under remote supervision via a digital monitoring portal, which tracks adherence, technical performance, and safety data in real time.
Locations (1)
Irccs Santa Lucia Foundation
Rome, ROME, Italy