Alternating electrical brain stimulation for Lewy body dementia
Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) on Cognitive Performance in Patients With Lewy Body Dementia
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 1 site (Brescia, Italy) |
| Trial ID | NCT07375771 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brescia, Italy
- IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli Brescia — Brescia, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.