NCT06785948 tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
| NCT ID | NCT06785948 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Association de Recherche Bibliographique pour les Neurosciences |
| Condition | Lewy Body Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-01-10 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Sandrine LOUCHART de la CHAPELLE, MD, PhD
PRINCIPAL INVESTIGATOR
Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)
Frequently Asked Questions
Who can join the NCT06785948 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Lewy Body Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06785948 currently recruiting?
Yes, NCT06785948 is actively recruiting participants. Contact the research team at kevin.polet@chpg.mc for enrollment information.
Where is the NCT06785948 trial being conducted?
This trial is being conducted at Monaco, Monaco.
Who is sponsoring the NCT06785948 clinical trial?
NCT06785948 is sponsored by Association de Recherche Bibliographique pour les Neurosciences. The principal investigator is Sandrine LOUCHART de la CHAPELLE, MD, PhD at Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO). The trial plans to enroll 30 participants.