NCT06785948Completed
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 9 Jan 2025
- Start date
- 10 Jan 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- Diseases
- Lewy body dementia
- NCT number
- NCT06785948
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 10 Jan 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant major psychiatric illness,
Other illness
- 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,
- Significant physical illness or comorbidities
- History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration,
Other
- Patient under guardianship or curators
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital Coordinator of this site? Confirm its status | Monaco | Monaco | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.