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

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).

Conditions

• Lewy Body Dementia
• Lewy Body Dementia With Behavioral Disturbance
• Burden, Caregiver
• Lewy Body Disease
• Dementia With Lewy Bodies

Interventions

DEVICE

active-tDCS

2mA stimulation (anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital). 10 sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).

DEVICE

Sham-tDCS

No intensity applied (anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital). 10 sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace

  collaborator OTHER

• Association des Aidants et Malades à Corps de Lewy (A2MCL)

  collaborator UNKNOWN

• Association de Recherche Bibliographique pour les Neurosciences

  lead OTHER

Principal Investigators

• Sandrine LOUCHART de la CHAPELLE, MD, PhD · Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-10

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• Monaco

Study Locations