RecruitingNot Applicable

tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden

Monaco30 participantsStarted 2025-01-10

Plain-language summary

The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD). The main questions it aims to answer are: * What is the effect of tDCS on neuropsychiatric symptoms, especially psychotic-like symptoms? * What is the impact of tDCS on caregiver burden? Researchers will compare active tDCS (2mA stimulation, anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital) to Sham tDCS (placebo stimulation, no intensity applied) to see if there is an effect on reducing psychotic-like symptoms and on caregiver burden. Participants will: * Undergo a stimulation phase consisting of 10 tDCS sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation). * perform assessments at T0 (inclusion), T1 (at the end of the stimulation phase), and T2 (follow-up at 8 weeks post stimulation).

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or Female, aged over 60, * Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria * No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion, * Mini Mental State Examination (MMSE) \> 15, * Composite score called "psychotic factor" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI \[12\]) greater than 0, * Presence of a family caregiver, * Sufficient written and oral expression in French, * Written informed consent signed by the patient and his/her family caregiver Exclusion Criteria: * History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which may lead to cognitive impairment, * Concomitant major psychiatric illness, * Significant physical illness or comorbidities * History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration, * Patient under guardianship or curators

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in the composite score named "psychotic factor" at T1

Timeframe: Baseline, Week 2

Change from Baseline in the composite score named "psychotic factor" at T2

Timeframe: Baseline, Week 10

Trial details

NCT IDNCT06785948

SponsorAssociation de Recherche Bibliographique pour les Neurosciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Kevin POLET, PhD

99995599 kevin.polet@chpg.mc

View on ClinicalTrials.gov More Lewy Body Dementia trials