Lewy Body Dementia (LBD) Clinical Trials

Find Lewy Body Dementia (LBD) Clinical Trials Near You

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