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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Monaco
Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
RECRUITING
Monaco
Contact Information
Primary
Kevin POLET, PhD
kevin.polet@chpg.mc
99995599
Backup
Solange HESSE
solange.hesse@chpg.mc
99995599
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2026-11
Participants
Target number of participants: 30
Treatments
Active_comparator: Active tDCS
Sham_comparator: Sham tDCS
Sponsors
Collaborators: Centre Hospitalier Princesse Grace, Association des Aidants et Malades à Corps de Lewy (A2MCL)
Leads: Association de Recherche Bibliographique pour les Neurosciences

This content was sourced from clinicaltrials.gov