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

Launched by ASSOCIATION DE RECHERCHE BIBLIOGRAPHIQUE POUR LES NEUROSCIENCES · Jan 20, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how a treatment called transcranial direct current stimulation (tDCS) can help reduce psychotic symptoms in people with Lewy Body Dementia (LBD). These symptoms can include hallucinations or delusions, which may be distressing for both patients and their caregivers. The study will compare the effects of real tDCS to a placebo (fake treatment) to see if it makes a difference in managing these symptoms and also how it impacts the burden on caregivers who support these patients.

To participate, individuals must be over 60 years old, diagnosed with moderate Lewy Body Dementia, and have certain cognitive abilities. They will undergo 10 sessions of tDCS over two weeks, each lasting 20 minutes. Throughout the trial, researchers will check in on participants at different points to assess any changes. It’s important to note that the study is not yet recruiting participants, and caregivers will also need to be involved in the process by providing consent and support.

Gender

ALL

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