Lewy Body Dementia (LBD)TACSDLB2NCT07375771

Transcranial Alternating Current Stimulation in Lewy Body Dementia

A study testing Transcranial Alternating Current Stimulation in people with Lewy Body Dementia (LBD) and Transcranial Alternating Current Stimulation, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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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 Lewy Body Dementia (DLB). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
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: 40 participants
Where: 2 sitesItaly
Study dates: 1 Oct 2025to Sep 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects aged over 18 at the time of signing the informed consent form;
Presence of a clinical diagnosis of Lewy body dementia according to clinical criteria (McKeith et al., 2017)

Who cannot join

Age younger than that stated in the inclusion criteria;
Incapacity to understand;
Contraindications for tACS and TMS: patients with cardiac pacemakers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety questionnaire)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites, 2 recruiting

IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia
Brescia, Italy, 25125
Barbara Borroni, MD, +39 0303501358, bborroni@fatebenefratelli.eu
+39 0303501360, sct.irccs@fatebenefratelli.eu
Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina di Trieste
Trieste, TS, 34139
Alberto Benussi, MD, +39 0403994282, benussialberto@gmail.com
Not yet recruiting

Other trials in Italy

About this study

Official title: Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Lewy Body Dementia

In neurodegenerative diseases, like DLB, the process of neurodegeneration is accompanied by a significant alteration in oscillatory activity.

tACS is a neurophysiological method of non-invasive modulation of the excitability of the central nervous system that uses a mild electrical current. Recent studies have demonstrated the safety and efficacy of this method in modulating the natural brain oscillation frequencies underlying multiple cognitive processes, such as verbal memory, perception, and working memory. Preliminary data show that single stimulation with occipital α-tACS results in a significant improvement in visuospatial abilities and executive functions in patients wih DLB.

The study is double blind, randomised and placebo-controlled, participants will be randomised into two groups: group 1, participants will receive real tACS for 2 weeks, from Wednesday to Tuesday (5 sessions/week, lasting approximately 60 minutes each); and group 2, participants will receive placebo tACS for 2 weeks (5 sessions/week, lasting approximately 60 minutes each).

Visits will take place at the beginning of the study (T00), after 2 weeks (T02), and 12 weeks (T12, follow-up). During each visit, participants undergo the following procedures: (i) blood sampling, (ii) clinical and neuropsychological assessment, (iii) EEG, and (iv) TMS-EEG. The occurrence of adverse events will be monitored throughout the duration of the study. Specific biomarker analyses will be performed on the blood samples to study the pathophysiological mechanisms of the disease and the effect of the experimental intervention.

Conditions: Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
Being tested: Transcranial Alternating Current Stimulation, Sham Transcranial Alternating Current Stimulation
Medical subject headings: Lewy Body Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Alternating Current StimulationDevice
10 sessions (5 days/week for 2 weeks), each consisting in the application of a tACS session (real at 3 mA) at the cortical level for a duration of 60 minutes each.
Sham Transcranial Alternating Current StimulationDevice
10 sessions (5 days/week for 2 weeks), each consisting in the application of a sham tACS session at the cortical level for a duration of 60 minutes each. The electrode placement will be identical to that used for real stimulation. However, the electrical current will be automatically interrupted approximately 5 seconds after the start of stimulation, making it impossible for the patient to distinguish between sham and real stimulation

Study groups in NCT07375771
Study group	Role	What they receive
Experimental: Real tACS	Experimental	10 sessions of Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session) Receives: Device: Transcranial Alternating Current Stimulation
Sham Comparator: Sham tACS	Sham comparator	10 sessions of sham Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session) Receives: Device: Sham Transcranial Alternating Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events of Transcranial Alternating Current Stimulation Protocol
Safety and tolerability will be assessed in terms of incidence and severity of any adverse events. Safety and tolerability will be monitored throughout the duration of the study.
Measured: Through study completion, at week 12
Feasibility of Transcranial Alternating Current Stimulation Protocol
Feasibility will be assessed based on the drop-out rate. Feasibility will be monitored throughout the duration of the study.
Measured: Through study completion, at week 12
Mini-Mental State Examination (MMSE)
The global cognitive functioning will be assessed by Mini-Mental State Examination (MMSE); MMSE scores range from 0 to 30, with higher scores indicating a more preserved cognition.
Measured: Change from baseline to week 12
Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) is designed to be a structured clinical interview about neuropsychiatric and behavioral symptoms will be assessed by; the score ranges from 0 (no symptoms) to 144 (severe symptoms).
Measured: Change from baseline to week 2 and 12
Qualitive Pentagon Test
Praxis-constructive abilities will be assessed by Qualitive Pentagon Test; the subject is asked to copy two intersecting pentagons. Qualitive Pentagon Test scores range from 0 to 13, with higher scores indicating a better performance.
Measured: Change from baseline to week 2 and 12
Rey Auditory Verbal Learning Test (RAVLT)
Verbal memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), including immediate recall (sum of trials), delayed recall after 15 minutes. Scores reflect the number of correctly recalled items.
Measured: Change from baseline to week 2 and 12
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: Change from baseline to week 2 and 12
Clock Drawing Test (CDT)
Constructional praxis abilities, mental representation skills, and visuospatial planning will be evaluated by Clock Drawing Test (CDT). CDT scores range from 0 to 15, with higher scores indicating a better performance.
Measured: Change from baseline to week 2 and 12
Rey-Osterrieth Complex Figure Test (ROCF)
Visuoconstructive abilities and visual memory will be assessed by Rey-Osterrieth Complex Figure. It requires the subject to copy a complex geometric figure and subsequently reproduce it from meory after a 10 minutes delay. Both tests score from 0 to 36, with higher score indicating a better performance.
Measured: Change from baseline to week 2 and 12
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: Change from baseline to week 2 and 12
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: Change from baseline to week 2 and 12
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: Change from baseline to week 2 and 12
Visual Search Task
Attention and cognitive flexibility will be assessed using a Visual Search task. Participants will be instructed to identify and select a predefined target each time it appears on the screen. Performance will be quantified by the number of correct detections (hits), missed targets (omissions), and incorrect responses (errors).
Measured: Change from baseline to week 2 and 12

Secondary outcomes (7)

Change in Biological Markers
A venous blood draw (35 ml) will be performed at each timepoint (T0, T02, T12). The samples will be processed for serum, plasma, and DNA extraction. Neurodegeneration biomarkers will be analyzed, specifically changes in plasma neurofilament light (NfL) levels (pg/mL) will be evaluated. The plasma biomarker profile will be evaluated as a predictor of treatment efficacy and correlated with differential treatment response.
Measured: Change from baseline to week 2 and 12
Change in electroencephalography (EEG)
Using resting-state electroencephalography (EEG) recorded under eyes-open and eyes-closed conditions, the investigators will assess changes in EEG alpha-band power (8-12 Hz). Alpha power will be quantified from scalp EEG recordings using spectral power analysis performed on the pre-processed EEG data.
Measured: Change from baseline to week 2 and 12
Change in TMS-EEG
Cortical reactivity and effective connectivity will be assessed by analyzing TMS-evoked potentials, obtained from TMS-EEG coregistration after occipital cortex stimulation.
Measured: Change from baseline to week 2 and 12
Basic Activities of Daily Living (BADL)
Basic Activities of Daily Living (BADL; range 0-6, higher scores indicating worse outcome) assesses the loss of daily self-sufficiency.
It will be evaluated as predictors of treatment efficacy and examined for associations with differential treatment response.
Measured: Baseline
Instrumental Activities of Daily Living (IADL)
Instrumental Activities of Daily Living (IADL; range 0-8, higher scores indicating worse outcome) assesses the loss of complex instrumental acitivities.
It will be evaluated as predictors of treatment efficacy and examined for associations with differential treatment response.
Measured: Baseline
Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III)
Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III; range 0-132, higher scores indicating worse outcome) assesses motor impairment.
It will be evaluated as predictors of treatment efficacy and examined for associations with differential treatment response.
Measured: Baseline
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.

1 Oct 2025Sep 2030

First posted29 Jan 2026
Study start1 Oct 2025
Primary completionSep 2027 (estimated)
Study completionSep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Lewy Body Dementia (LBD)Studies 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: Parallel groups
Model description: The study is a double-blind, randomised and placebo-controlled trial, participants will be randomised into two groups: group 1, participants will receive real tACS for 2 weeks; and group 2, placebo tACS 2 weeks. Each participant will receive a total of 2 weeks of intervention, with 5 sessions per week (Wednesday to Tuesday) lasting approximately 60 minutes each.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07375771
Sponsor's protocol ID: TACSDLB2
Acronym: TACSDLB2
Status last verified: Nov 2026
First submitted: 1 Dec 2025
Last updated: 5 Nov 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Aoki Y, Kazui H, Pascal-Marqui RD, Ishii R, Yoshiyama K, Kanemoto H, Suzuki Y, Sato S, Hata M, Canuet L, Iwase M, Ikeda M. EEG Resting-State Networks in Dementia with Lewy Bodies Associated with Clinical Symptoms. Neuropsychobiology. 2019;77(4):206-218. doi: 10.1159/000495620. Epub 2019 Jan 17.
PubMed 30654367
Antal 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 28709880
Amodio 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
Bagattini C, Mutanen TP, Fracassi C, Manenti R, Cotelli M, Ilmoniemi RJ, Miniussi C, Bortoletto M. Predicting Alzheimer's disease severity by means of TMS-EEG coregistration. Neurobiol Aging. 2019 Aug;80:38-45. doi: 10.1016/j.neurobiolaging.2019.04.008. Epub 2019 Apr 13.
PubMed 31077959
Benussi 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 39136447
Bonato C, Miniussi C, Rossini PM. Transcranial magnetic stimulation and cortical evoked potentials: a TMS/EEG co-registration study. Clin Neurophysiol. 2006 Aug;117(8):1699-707. doi: 10.1016/j.clinph.2006.05.006. Epub 2006 Jun 22.
PubMed 16797232
Bortoletto M, Veniero D, Thut G, Miniussi C. The contribution of TMS-EEG coregistration in the exploration of the human cortical connectome. Neurosci Biobehav Rev. 2015 Feb;49:114-24. doi: 10.1016/j.neubiorev.2014.12.014. Epub 2014 Dec 22.
PubMed 25541459
Hoy KE, Bailey N, Arnold S, Windsor K, John J, Daskalakis ZJ, Fitzgerald PB. The effect of gamma-tACS on working memory performance in healthy controls. Brain Cogn. 2015 Dec;101:51-6. doi: 10.1016/j.bandc.2015.11.002. Epub 2015 Nov 12.
PubMed 26580743
Massimini M, Ferrarelli F, Huber R, Esser SK, Singh H, Tononi G. Breakdown of cortical effective connectivity during sleep. Science. 2005 Sep 30;309(5744):2228-32. doi: 10.1126/science.1117256.
PubMed 16195466
Monaco 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 22689311
Morishima Y, Akaishi R, Yamada Y, Okuda J, Toma K, Sakai K. Task-specific signal transmission from prefrontal cortex in visual selective attention. Nat Neurosci. 2009 Jan;12(1):85-91. doi: 10.1038/nn.2237. Epub 2008 Dec 21.
PubMed 19098905
Morrin H, Fang T, Servant D, Aarsland D, Rajkumar AP. Systematic review of the efficacy of non-pharmacological interventions in people with Lewy body dementia. Int Psychogeriatr. 2018 Mar;30(3):395-407. doi: 10.1017/S1041610217002010. Epub 2017 Oct 9.
PubMed 28988547
Nitsche 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 20633386
Treisman AM, Gelade G. A feature-integration theory of attention. Cogn Psychol. 1980 Jan;12(1):97-136. doi: 10.1016/0010-0285(80)90005-5. No abstract available.
PubMed 7351125
Ragazzoni A, Pirulli C, Veniero D, Feurra M, Cincotta M, Giovannelli F, Chiaramonti R, Lino M, Rossi S, Miniussi C. Vegetative versus minimally conscious states: a study using TMS-EEG, sensory and event-related potentials. PLoS One. 2013;8(2):e57069. doi: 10.1371/journal.pone.0057069. Epub 2013 Feb 27.
PubMed 23460826

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
RecruitingPhase 2
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Cognitive Dysfunction, Lewy Body Disease
RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)

All Lewy Body Dementia (LBD) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Lewy Body Dementia
ClinicalTrials.gov ID: NCT07375771
Acronym / sponsor ID: TACSDLB2 / TACSDLB2
Conditions: Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
Study start: 1 Oct 2025 (actual)
Primary completion: Sep 2027 (estimated)
Study completion: Sep 2030 (estimated)
First posted: 29 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In neurodegenerative diseases, like DLB, the process of neurodegeneration is accompanied by a significant alteration in oscillatory activity.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: The study is a double-blind, randomised and placebo-controlled trial, participants will be randomised into two groups: group 1, participants will receive real tACS for 2 weeks; and group 2, placebo tACS 2 weeks. Each participant will receive a total of 2 weeks of intervention, with 5 sessions per week (Wednesday to Tuesday) lasting approximately 60 minutes each.

Arm	Type	Receives
Experimental: Real tACS	Experimental	Device: Transcranial Alternating Current Stimulation10 sessions of Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)
Sham Comparator: Sham tACS	Sham comparator	Device: Sham Transcranial Alternating Current Stimulation10 sessions of sham Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female subjects aged over 18 at the time of signing the informed consent form;
Presence of a clinical diagnosis of Lewy body dementia according to clinical criteria (McKeith et al., 2017)

Key exclusion criteria (3 listed)

Age younger than that stated in the inclusion criteria;
Incapacity to understand;
Contraindications for tACS and TMS: patients with cardiac pacemakers and metal implants that are not compatible with electric or magnetic fields, history of epilepsy, current pregnancy (Safety questionnaire)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Alternating Current Stimulation10 sessions (5 days/week for 2 weeks), each consisting in the application of a tACS session (real at 3 mA) at the cortical level for a duration of 60 minutes each.	Device	Experimental: Real tACS
Sham Transcranial Alternating Current Stimulation10 sessions (5 days/week for 2 weeks), each consisting in the application of a sham tACS session at the cortical level for a duration of 60 minutes each. The electrode placement will be identical to that used for real stimulation. However, the electrical current will be automatically interrupted approximately 5 seconds after the start of stimulation, making it impossible for the patient to distinguish between sham and real stimulation	Device	Sham Comparator: Sham tACS

Primary outcome

Incidence of Treatment-Emergent Adverse Events of Transcranial Alternating Current Stimulation Protocol
Time frame: Through study completion, at week 12
Safety and tolerability will be assessed in terms of incidence and severity of any adverse events. Safety and tolerability will be monitored throughout the duration of the study.
Feasibility of Transcranial Alternating Current Stimulation Protocol
Time frame: Through study completion, at week 12
Feasibility will be assessed based on the drop-out rate. Feasibility will be monitored throughout the duration of the study.
Mini-Mental State Examination (MMSE)
Time frame: Change from baseline to week 12
The global cognitive functioning will be assessed by Mini-Mental State Examination (MMSE); MMSE scores range from 0 to 30, with higher scores indicating a more preserved cognition.
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline to week 2 and 12
Neuropsychiatric Inventory (NPI) is designed to be a structured clinical interview about neuropsychiatric and behavioral symptoms will be assessed by; the score ranges from 0 (no symptoms) to 144 (severe symptoms).
Qualitive Pentagon Test
Time frame: Change from baseline to week 2 and 12
Praxis-constructive abilities will be assessed by Qualitive Pentagon Test; the subject is asked to copy two intersecting pentagons. Qualitive Pentagon Test scores range from 0 to 13, with higher scores indicating a better performance.
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Change from baseline to week 2 and 12
Verbal memory will be assessed using the Rey Auditory Verbal Learning Test (RAVLT), including immediate recall (sum of trials), delayed recall after 15 minutes. Scores reflect the number of correctly recalled items.
Trail Making Test (TMT - AB)
Time frame: Change from baseline to week 2 and 12
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.
Clock Drawing Test (CDT)
Time frame: Change from baseline to week 2 and 12
Constructional praxis abilities, mental representation skills, and visuospatial planning will be evaluated by Clock Drawing Test (CDT). CDT scores range from 0 to 15, with higher scores indicating a better performance.
Rey-Osterrieth Complex Figure Test (ROCF)
Time frame: Change from baseline to week 2 and 12
Visuoconstructive abilities and visual memory will be assessed by Rey-Osterrieth Complex Figure. It requires the subject to copy a complex geometric figure and subsequently reproduce it from meory after a 10 minutes delay. Both tests score from 0 to 36, with higher score indicating a better performance.
Phonemic Fluency Test
Time frame: Change from baseline to week 2 and 12
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.
Semantic Fluency Test
Time frame: Change from baseline to week 2 and 12
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.
Digit Span Test
Time frame: Change from baseline to week 2 and 12
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.
Visual Search Task
Time frame: Change from baseline to week 2 and 12
Attention and cognitive flexibility will be assessed using a Visual Search task. Participants will be instructed to identify and select a predefined target each time it appears on the screen. Performance will be quantified by the number of correct detections (hits), missed targets (omissions), and incorrect responses (errors).

7 secondary outcomes

Change in Biological Markers
Time frame: Change from baseline to week 2 and 12
Change in electroencephalography (EEG)
Time frame: Change from baseline to week 2 and 12
Change in TMS-EEG
Time frame: Change from baseline to week 2 and 12
Basic Activities of Daily Living (BADL)
Time frame: Baseline
Instrumental Activities of Daily Living (IADL)
Time frame: Baseline
Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III)
Time frame: Baseline
Demographic characteristics
Time frame: Baseline

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Background: PubMed 30654367Aoki Y, Kazui H, Pascal-Marqui RD, Ishii R, Yoshiyama K, Kanemoto H, Suzuki Y, Sato S, Hata M, Canuet L, Iwase M, Ikeda M. EEG Resting-State Networks in Dementia with Lewy Bodies Associated with Clinical Symptoms. Neuropsychobiology. 2019;77(4):206-218. doi: 10.1159/000495620. Epub 2019 Jan 17.
Background: PubMed 28709880Antal 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.
Background: PubMed 12092785Amodio 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.
Background: PubMed 31077959Bagattini C, Mutanen TP, Fracassi C, Manenti R, Cotelli M, Ilmoniemi RJ, Miniussi C, Bortoletto M. Predicting Alzheimer's disease severity by means of TMS-EEG coregistration. Neurobiol Aging. 2019 Aug;80:38-45. doi: 10.1016/j.neurobiolaging.2019.04.008. Epub 2019 Apr 13.
Background: PubMed 39136447Benussi 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.
Background: PubMed 16797232Bonato C, Miniussi C, Rossini PM. Transcranial magnetic stimulation and cortical evoked potentials: a TMS/EEG co-registration study. Clin Neurophysiol. 2006 Aug;117(8):1699-707. doi: 10.1016/j.clinph.2006.05.006. Epub 2006 Jun 22.
Background: PubMed 25541459Bortoletto M, Veniero D, Thut G, Miniussi C. The contribution of TMS-EEG coregistration in the exploration of the human cortical connectome. Neurosci Biobehav Rev. 2015 Feb;49:114-24. doi: 10.1016/j.neubiorev.2014.12.014. Epub 2014 Dec 22.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia

Brescia, Italy

+39 0303501358

bborroni@fatebenefratelli.eu

Azienda Sanitaria Universitaria Giuliano Isontina di Trieste

Trieste, Italy

+39 0403994282

benussialberto@gmail.com

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events of Transcranial Alternating Current Stimulation Protocol (time frame: Through study completion, at week 12). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07375771, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.