NCT07505784

Transcranial Alternating Current Stimulation in Frontotemporal Dementia

Cross-over Study to Evaluate the Safety, Tolerability, and Clinical Efficacy of Transcranial Alternating Current Stimulation (tACS) in Patients With Frontotemporal Dementia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of transcranial alternating current stimulation (tACS) in patients with Frontotemporal Dementia (FTD). In addition to typical symptoms, FTD also present alterations in brain oscillations. In animal models of neurodegeneration, restoration of oscillations via neuronal "entrainment" phenomena has demonstrated a significant reduction in toxic protein accumulation, resulting in improved cognitive function. tACS is a neurophysiological noninvasive method of neuromodulation increasingly studied for its therapeutic potential. It has been shown to safely modulate the oscillatory frequencies underlying multiple cognitive functions, including verbal memory, perception, and working memory. In light of this evidence, it is proposed to apply a single-session treatment of β-tACS stimulation in patients with FTD and to evaluate its clinical effects, oscillatory modifications by EEG, and changes in neurophysiological indices such as short intracortical inhibition (SICI) and intracortical facilitation (ICF), both compromised in the disease. The study has a cross-over design (multicenter, randomized, placebo-controlled and double-blind), with FTD patients randomly assigned to one of the two arms: i) Group 1, who will receive a real tACS session first (1h); ii) Group 2, who will instead undergo a sham tACS session (1h). In the next phase (cross-over), one week after the first phase, the groups will reverse the treatment: Group 1 will receive tACS sham and Group 2 will receive real tACS. The main objectives of the study are: \[1\] to evaluate the safety and tolerability of the single tACS treatment session; \[2\] to investigate the effects of the protocol on (short-term) cognitive performance in patients with FTD; \[3\] to verify intervention-induced changes in brain synchronization; \[4\] to evaluate changes in neurophysiological indices following treatment; and \[5\] evaluate any predictors of efficacy.

Conditions

• Transcranial Alternating Current Stimulation
• Frontotemporal Dementia (FTD)

Interventions

Type	Name	Description
DEVICE	Transcranial Alternating Current Stimulation	The session will consist of the application of a session of tACS (real at 2.5 mA) at the cortical level for a duration of 60 minutes.
DEVICE	Sham Transcranial Alternating Current Stimulation	Application of sham tACS session at the cortical level for a duration of 60 minutes. The electrode placement will be identical to that used for real stimulation. However, the electrical current will be automatically interrupted approximately 30 seconds after the start of stimulation, making it impossible for the patient to distinguish between sham and real stimulation.

Timeline

• Start date: 2026-02-03
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: Italy