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NCT Number: NCT07375771

Transcranial Alternating Current Stimulation in 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.

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Key information

Conditions

Lewy Body Dementia (LBD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies Transcranial Alternating Current Stimulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial Alternating Current Stimulation

Device

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 stimulation

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  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.

  13. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Registry information

Official study title

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

Acronym: TACSDLB2

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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