Alternating electrical brain stimulation for Lewy body dementia
Official title: Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Lewy Body Dementia
Run by IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT07375771 · Data updated 2026-11-12
This will test whether mild alternating electrical stimulation of the brain (tACS) is safe and can improve thinking, memory, and visual‑spatial skills in adults with Lewy body dementia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 2 sites (Brescia, Italy and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2030 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07375771 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a clinical diagnosis of Lewy body dementia (per McKeith et al. 2017) who can give informed consent and have no contraindications to tACS or TMS are the intended participants.
✕Probably not a fit
People with contraindications to electrical or magnetic stimulation (for example incompatible pacemakers, certain metal implants, a history of epilepsy), current pregnancy, or who cannot consent are unlikely to participate or benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with a clinical diagnosis of Lewy body dementia are randomized in a double‑blind design to receive either active transcranial alternating current stimulation (tACS) or sham stimulation. The intervention targets oscillatory brain activity (for example occipital alpha frequencies) using a noninvasive, low‑intensity electrical current. Outcomes include safety and feasibility measures, clinical cognitive testing, and biological markers related to brain rhythms (such as EEG changes) to identify predictors of response. The protocol compares single or repeated stimulation sessions against placebo stimulation to determine short‑term cognitive and physiological effects.
Why it matters
Potential benefit: If successful, this could provide a noninvasive, low‑risk way to improve cognitive and visuospatial symptoms in people with Lewy body dementia.
How similar studies have gone: Preliminary and small studies show tACS can safely modulate brain rhythms and single‑session occipital alpha‑tACS produced short‑term improvements in visuospatial and executive function in small DLB samples, but larger randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia
Brescia, Italy, Italy Recruiting -
Azienda Sanitaria Universitaria Giuliano Isontina di Trieste
Trieste, Ts, Italy Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.