EEG Resting-State Networks in Dementia with Lewy Bodies Associated with Clinical Symptoms.
Yasunori Aoki, Hiroaki Kazui, Roberto D Pascal-Marqui...
https://pubmed.ncbi.nlm.nih.gov/30654367Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07375771
Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation on Cognitive Performance in Patients With Lewy Body Dementia
Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2026-01-29
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, feasibility, and effects of transcranial alternating current stimulation (tACS) in people with Lewy Body Dementia (DLB). This study aims to understand how tACS, a non-invasive brain stimulation method using mild electrical currents, influences brain activity and cognitive functions like memory and perception in DLB patients. The trial is double-blind, randomized, and placebo-controlled to compare real tACS with placebo treatment. Participants will be randomly assigned to one of two groups: one group will receive real tACS sessions and the other will receive sham (placebo) tACS sessions. Both groups will undergo 10 sessions over two weeks, with five sessions per week, each lasting about 60 minutes. The sham group will receive brief stimulation that stops after a few seconds, mimicking the real procedure without ongoing electrical current. During the study, participants will visit at the start, after two weeks, and again at 12 weeks for follow-up. At each visit, they will undergo blood tests, clinical and neuropsychological assessments, EEG and TMS-EEG brain recordings. Researchers will monitor for any adverse events throughout the study and analyze biological markers to understand disease mechanisms and treatment effects. The primary outcomes include safety, feasibility, and changes in cognitive tests over 12 weeks.
CONDITIONS
Brief Title
Transcranial Alternating Current Stimulation in Lewy Body Dementia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged over 18 at the time of signing the informed consent form
- Clinical diagnosis of Lewy Body Dementia according to clinical criteria (McKeith et al., 2017)
You will not qualify if you...
- Age younger than 18 years
- Incapacity to understand the study
- Contraindications for tACS and TMS including cardiac pacemakers or metal implants incompatible with electric or magnetic fields
- History of epilepsy
- Current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - 2 weeks
Participants receive 10 sessions of Transcranial Alternating Current Stimulation or sham stimulation over 2 weeks.
10 sessions (5 sessions per week, 60 minutes each)
Follow-up
Duration - Up to 10 weeks after treatment
Participants are monitored for safety and cognitive performance changes after the stimulation sessions.
Visits at week 2 and week 12 post-treatment
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia
Brescia, Italy, Italy, 25125
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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