Actively Recruiting
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
Led by Association de Recherche Bibliographique pour les Neurosciences · Updated on 2025-10-01
30
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
Sponsors
A
Association de Recherche Bibliographique pour les Neurosciences
Lead Sponsor
C
Centre Hospitalier Princesse Grace
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female, aged over 60
- Diagnosed with a neurodegenerative pathology of the DLB type at a moderate stage according to McKeith et al. (2017) criteria
- No change in antiparkinsonian, psychotropic medications, or cholinesterase inhibitors for at least one month before inclusion
- Mini Mental State Examination (MMSE) score greater than 15
- Composite "psychotic factor" score greater than 0 from the Neuropsychiatric Inventory (NPI)
- Presence of a family caregiver
- Sufficient written and oral expression in French
- Written informed consent signed by the patient and caregiver
You will not qualify if you...
- History of alcoholism, drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, or intracranial normal-pressure hydrocephalus
- Concomitant major psychiatric illness
- Significant physical illness or comorbidities
- History of moderate to severe visual impairment due to glaucoma, cataract, or macular degeneration
- Patient under guardianship or curatorship
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, Monaco, 98000
Actively Recruiting
Research Team
K
Kevin POLET, PhD
CONTACT
S
Solange HESSE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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