An interventional study of Transcranial Alternating Current Stimulation and Sham Transcranial Alternating Current Stimulation in Transcranial Alternating Current Stimulation and Frontotemporal Dementia (FTD), sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 1 site in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Not applicable, Interventional, and Treatment
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.
208 studies on the registry are indexed under Frontotemporal Dementia; 72 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 128 interventional studies indexed under Frontotemporal Dementia.
Browse Frontotemporal Dementia studies →IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1, who will undergo real tACS treatment, in a single 60-minute session and after one week of sham tACS treatment, in a single 60-minute session.
Device: Transcranial Alternating Current Stimulation · Device: Sham Transcranial Alternating Current Stimulation
Group 2, who will undergo sham tACS treatment, in a single 60-minute session and after one week of real tACS treatment, in a single 60-minute session.
Device: Transcranial Alternating Current Stimulation · Device: Sham 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.
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.
Safety and Feasibility of Transcranial Alternating Current Stimulation Protocol
Safety will be assessed in terms of the frequency and severity of any adverse events, and feasibility will be assessed based on the study dropout rate. Safety and feasibility will be monitored throughout the study.
Time frame: Periprocedurally, an average 1 week
Phonemic Fluency Test
Cognitive flexibility and verbal fluency will be evalueted by Phonemic Fluency Test. Subject is asked to generate as many words as possible from a given letter within a limited time (60 seconds); higher scores indicate better perfomance.
Time frame: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
Semantic Fluency Test
Lexical-semantic access and executive functioning will be evalueted by Semantic Fluency Test. Subject is asked to generate as many words as possible from a given category within a limited time (60 seconds); higher scores indicate better perfomance.
Time frame: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
Trail Making Test (TMT - AB)
Executive function will be assessed using the Trail Making Test, including Part A (visual attention and processing speed) and Part B (task switching and cognitive flexibility). Higher completion times reflect poorer performance.
Time frame: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
Digit Span Test
Short-term memory and working memory will be assessed respectively using the Digit Span forward and Digit Span backward. Scores reflect the maximum number of digits recalled in correct order.
Time frame: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
Modified Emotion Recognition Test
Emotion recognition from facial expressions will be evalueted by Modified Emotion Recognition Test. Subject is asked to choose an emotion from five options for each face showed; higher scores indicate better perfomance.
Time frame: Immediately after first stimulation. Immediately after second stimulation, after a week.
Berg's Card Sorting Task
Cognitive flexibility and problem solving will be assessed by Berg's Card Sorting Task. Scores reflect correct answer, errors and reaction time.
Time frame: At the end of first stimulation. At the end of second stimulation, after a week.
Go/No-Go Task
Inhibition control will be assessed by Go/No-Go Task. Scores reflect correct targets, false alarms, misses and response speed.
Time frame: At the end of first stimulation. At the end of second stimulation, after a week.
Change in electroencephalography (EEG)
Using resting-state EEG recorded under eyes-open and eyes-closed conditions, the investigators will assess changes in EEG beta-band power (13-30 Hz). Beta power will be quantified from scalp EEG recordings using spectral power analysis performed on the pre-processed EEG data.
Time frame: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
Effectiveness in restoring neurotransmission
Neurotransmission will be assessed by measuring changes in glutamatergic (intracortical facilitation, ICF) and GABAergic (short-interval intracortical inhibition, SICI) neurotransmission assessed indirectly through TMS.
Time frame: Immediately before and immediately after first stimulation. Immediately before and immediately after second stimulation, after a week.
Demographic characteristics
Demographic characteristics (age, gender, and level of education) will be evaluated as predictors of treatment efficacy and examined for associations with differential treatment response.
Time frame: Baseline
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 51 non-industry interventional studies with no phase under Frontotemporal Dementia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 97. This study's planned 10 months is below that.
Counting every sponsor, half of 54 studies reached it within 41 months; a quarter within 21 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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IRCCS Centro San Giovanni di Dio Fatebenefratelli