An interventional study of Transcranial Alternating Current Stimulation and Sham Transcranial Alternating Current Stimulation in Lewy Body Dementia (LBD) and Transcranial Alternating Current Stimulation, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
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 Lewy Body Dementia (DLB).
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.
Exclusion Criteria:
10 sessions of Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)
Device: Transcranial Alternating Current Stimulation
10 sessions of sham Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)
Device: Sham Transcranial Alternating Current Stimulation
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Change from baseline to week 2 and 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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IRCCS Centro San Giovanni di Dio Fatebenefratelli