Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the DMN in Mild AD Patients

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

August 31, 2026

Conditions
Alzheimer Disease
Interventions
DEVICE

Combined iTBS-tACS

The iTBS-tACS will be applied over the precuneus and last for 190 s, with the tACS electrode positioned on the scalp and the iTBS coil positioned just above it. The iTBS protocol will consist of 600 pulses, delivered in 20 trains of 10 bursts with an interval of 8 seconds between each train. Each burst consists of three pulses at 50Hz, repeated at 5Hz. The total duration will therefore be 190 seconds. iTBS and tACS will be synchronized using a BrainTrigger and SIGNAL Software so that both stimulations will start simultaneously

DEVICE

iTBS-sham tACS

"The iTBS-tACS will be applied over the precuneus and last for 190 s, with the tACS electrode positioned on the scalp and the iTBS coil positioned just above it. The iTBS protocol will consist of 600 pulses, delivered in 20 trains of 10 bursts with an interval of 8 seconds between each train. Each burst consists of three pulses at 50Hz, repeated at 5Hz. The total duration will therefore be 190 seconds.~For the tACS sham condition, the electric current will not be applied, but there will be a 2 s 1 mA ramp up and 2 s 1 mA ramp down, to give the participant real stimulation feelings."

DEVICE

sham iTBS- sham tACS

"The iTBS-tACS will be applied over the precuneus and last for 190 s, with the tACS electrode positioned on the scalp and the iTBS coil positioned just above it. The iTBS protocol will consist of 600 pulses, delivered in 20 trains of 10 bursts with an interval of 8 seconds between each train. Each burst consists of three pulses at 50Hz, repeated at 5Hz. The total duration will therefore be 190 seconds.~For the iTBS sham condition, stimulation was delivered with the coil angled at 90°, with only the edge of the coil resting on the scalp..~For the tACS sham condition, the electric current will not be applied, but there will be a 2 s 1 mA ramp up and 2 s 1 mA ramp down, to give the participant real stimulation feelings."

Trial Locations (2)

98124

NOT_YET_RECRUITING

I.R.C.C.S. Centro Neurolesi Bonino Pulejo, Messina

00179

RECRUITING

IRCCS Santa Lucia Foundation, Rome

All Listed Sponsors
collaborator

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

lead

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

OTHER