Transcranial Alternating Current StimulationBetaTACSFTDNCT07505784
Transcranial Alternating Current Stimulation in Frontotemporal Dementia
A study testing Transcranial Alternating Current Stimulation in people with Transcranial Alternating Current Stimulation and Frontotemporal Dementia (FTD), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Transcranial Alternating Current Stimulation, Frontotemporal Dementia (FTD)
- What is being tested?
- Transcranial Alternating Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli
Brescia, BS, 25125
Barbara Borroni, MD, +39 0303501358, bborroni@fatebenefratelli.eu
Barbara Borroni, MD
About this study
Official title: Cross-over Study to Evaluate the Safety, Tolerability, and Clinical Efficacy of Transcranial Alternating Current Stimulation (tACS) in Patients With Frontotemporal Dementia
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.
Read more
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.
- Being tested
- Transcranial Alternating Current Stimulation, Sham Transcranial Alternating Current Stimulation
- Medical subject headings
- Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current StimulationDevice
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.
Sham Transcranial Alternating Current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | 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. Receives: Device: Transcranial Alternating Current Stimulation; Device: Sham Transcranial Alternating Current Stimulation |
| Group 2 | Other | 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. Receives: Device: Transcranial Alternating Current Stimulation; Device: Sham Transcranial Alternating Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of first stimulation. At the end of second stimulation, after a week.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start3 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Transcranial Alternating Current StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a randomized, double-blind, cross-over study designed to evaluate the effects of tACS on cognitive performance and neurophysiological parameters.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Barbara Borroni, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505784
- Sponsor's protocol ID
- BetaTACSFTD
- Acronym
- BetaTACSFTD
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rascovsky K, Hodges JR, Knopman D, Mendez MF, Kramer JH, Neuhaus J, van Swieten JC, Seelaar H, Dopper EG, Onyike CU, Hillis AE, Josephs KA, Boeve BF, Kertesz A, Seeley WW, Rankin KP, Johnson JK, Gorno-Tempini ML, Rosen H, Prioleau-Latham CE, Lee A, Kipps CM, Lillo P, Piguet O, Rohrer JD, Rossor MN, Warren JD, Fox NC, Galasko D, Salmon DP, Black SE, Mesulam M, Weintraub S, Dickerson BC, Diehl-Schmid J, Pasquier F, Deramecourt V, Lebert F, Pijnenburg Y, Chow TW, Manes F, Grafman J, Cappa SF, Freedman M, Grossman M, Miller BL. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2456-77. doi: 10.1093/brain/awr179. Epub 2011 Aug 2.
PubMed 21810890Pettorruso M, Miuli A, Di Natale C, Montemitro C, Zoratto F, De Risio L, d'Andrea G, Dannon PN, Martinotti G, di Giannantonio M. Non-invasive brain stimulation targets and approaches to modulate gambling-related decisions: A systematic review. Addict Behav. 2021 Jan;112:106657. doi: 10.1016/j.addbeh.2020.106657. Epub 2020 Sep 13.
PubMed 32987305Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
PubMed 20633386Nishida K, Yoshimura M, Isotani T, Yoshida T, Kitaura Y, Saito A, Mii H, Kato M, Takekita Y, Suwa A, Morita S, Kinoshita T. Differences in quantitative EEG between frontotemporal dementia and Alzheimer's disease as revealed by LORETA. Clin Neurophysiol. 2011 Sep;122(9):1718-25. doi: 10.1016/j.clinph.2011.02.011. Epub 2011 Mar 10.
PubMed 21396882Monaco M, Costa A, Caltagirone C, Carlesimo GA. Forward and backward span for verbal and visuo-spatial data: standardization and normative data from an Italian adult population. Neurol Sci. 2013 May;34(5):749-54. doi: 10.1007/s10072-012-1130-x. Epub 2012 Jun 12.
PubMed 22689311Lindau M, Jelic V, Johansson SE, Andersen C, Wahlund LO, Almkvist O. Quantitative EEG abnormalities and cognitive dysfunctions in frontotemporal dementia and Alzheimer's disease. Dement Geriatr Cogn Disord. 2003;15(2):106-14. doi: 10.1159/000067973.
PubMed 12566600Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
PubMed 15753425Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R, Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM, Grossman M. Classification of primary progressive aphasia and its variants. Neurology. 2011 Mar 15;76(11):1006-14. doi: 10.1212/WNL.0b013e31821103e6. Epub 2011 Feb 16.
PubMed 21325651Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21.
PubMed 23963806Caffarra P, Vezzadini G, Dieci F, Zonato F, Venneri A. Rey-Osterrieth complex figure: normative values in an Italian population sample. Neurol Sci. 2002 Mar;22(6):443-7. doi: 10.1007/s100720200003.
PubMed 11976975Benussi A, Grassi M, Palluzzi F, Koch G, Di Lazzaro V, Nardone R, Cantoni V, Dell'Era V, Premi E, Martorana A, di Lorenzo F, Bonni S, Ranieri F, Capone F, Musumeci G, Cotelli MS, Padovani A, Borroni B. Classification Accuracy of Transcranial Magnetic Stimulation for the Diagnosis of Neurodegenerative Dementias. Ann Neurol. 2020 Mar;87(3):394-404. doi: 10.1002/ana.25677. Epub 2020 Jan 23.
PubMed 31925823Benussi A, Cantoni V, Rivolta J, Zoppi N, Cotelli MS, Bianchi M, Cotelli M, Borroni B. Alpha tACS Improves Cognition and Modulates Neurotransmission in Dementia with Lewy Bodies. Mov Disord. 2024 Nov;39(11):1993-2003. doi: 10.1002/mds.29969. Epub 2024 Aug 13.
PubMed 39136447Benussi A, Cantoni V, Grassi M, Brechet L, Michel CM, Datta A, Thomas C, Gazzina S, Cotelli MS, Bianchi M, Premi E, Gadola Y, Cotelli M, Pengo M, Perrone F, Scolaro M, Archetti S, Solje E, Padovani A, Pascual-Leone A, Borroni B. Increasing Brain Gamma Activity Improves Episodic Memory and Restores Cholinergic Dysfunction in Alzheimer's Disease. Ann Neurol. 2022 Aug;92(2):322-334. doi: 10.1002/ana.26411. Epub 2022 Jun 6.
PubMed 35607946Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
PubMed 28709880Amodio P, Wenin H, Del Piccolo F, Mapelli D, Montagnese S, Pellegrini A, Musto C, Gatta A, Umilta C. Variability of trail making test, symbol digit test and line trait test in normal people. A normative study taking into account age-dependent decline and sociobiological variables. Aging Clin Exp Res. 2002 Apr;14(2):117-31. doi: 10.1007/BF03324425.
PubMed 12092785