Digital Twins for Model-driven Non-invasive Electrical Brain Stimulation

NAActive, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 4, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Alzheimer Disease
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (1)

00179

Irccs Santa Lucia Foundation, Rome

All Listed Sponsors
lead

I.R.C.C.S. Fondazione Santa Lucia

OTHER