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
- Transcranial Alternating Current Stimulation
- Frontotemporal Dementia (FTD)
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Enrolment target
- 30
- Started
- 3 February 2026
- Main results due
- December 2026
- Study sites
- 1
- Registry updated
- 24 September 2026
Can you take part?
- Aged 40 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Male or female subjects aged over 40 years at the time of signing the informed consent form; * Presence of a clinical diagnosis of Frontotemporal Dementia according to clinical criteria (Rascovsky et al., 2011; Gorno-Tempini et al., 2011). Exclusion Criteria: * Age younger than that stated in the inclusion criterion; * Inability to understand; * Contraindications for tACS and TMS: cardiac pacemaker carriers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety Questionnaire)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli
Brescia, BS, Italy
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07505784. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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