Transcranial Alternating Current Stimulation in Lewy Body Dementia

NCT07375771 | Recruiting

• 1 other identifier: TACSDLB2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  Change from baseline to week 2 and 12

Secondary Outcomes (7)

• Change in Biological Markers

  Change from baseline to week 2 and 12

• Change in electroencephalography (EEG)

  Change from baseline to week 2 and 12

• Change in TMS-EEG

  Change from baseline to week 2 and 12

• Basic Activities of Daily Living (BADL)

  Baseline

• Instrumental Activities of Daily Living (IADL)

  Baseline

Study Arms (2)

Experimental: Real tACS

EXPERIMENTAL

10 sessions of Transcranial Alternating Current Stimulation (5 sessions/week, 60 minutes/session)

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)

Device: Sham Transcranial Alternating Current Stimulation

Interventions

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

Sham Comparator: Sham tACS

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.

Experimental: Real tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (1)

IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia

Brescia, Italy, 25125, Italy

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Lewy Body Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 29, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: January 29, 2026

Record last verified: 2025-09

Locations

IT (1)