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 range60 Years

SexALL

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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

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