Transcranial Alternating Current Stimulation in Lewy Body Dementia (TACSDLB2)

January 21, 2026 updated by: Prof. Barbara Borroni, IRCCS Centro San Giovanni di Dio Fatebenefratelli

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Brescia, Italy, Italy, 25125
        • Recruiting
        • IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia
        • Principal Investigator:
          • Barbara Borroni, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Real tACS
10 sessions of Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)
Device: 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.
Sham Comparator: Sham Comparator: Sham tACS
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, at week 12
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.
Through study completion, at week 12
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.
Change from baseline to week 12
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).
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
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).
Change from baseline to week 2 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Biological Markers
Time Frame: Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
Change in electroencephalography (EEG)
Time Frame: Change from baseline to week 2 and 12
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.
Change from baseline to week 2 and 12
Change in TMS-EEG
Time Frame: Change from baseline to week 2 and 12
Cortical reactivity and effective connectivity will be assessed by analyzing TMS-evoked potentials, obtained from TMS-EEG coregistration after occipital cortex stimulation.
Change from baseline to week 2 and 12
Basic Activities of Daily Living (BADL)
Time Frame: Baseline

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.
Baseline
Instrumental Activities of Daily Living (IADL)
Time Frame: Baseline

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.
Baseline
Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III)
Time Frame: Baseline

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.
Baseline
Demographic characteristics
Time Frame: Baseline
Demographic characteristics (age, gender, and level of education) will be evaluated as predictors of treatment efficacy and examined for associations with differential treatment response.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACSDLB2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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