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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAssociation de Recherche Bibliographique pour les Neurosciences

About this trial

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 criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • active-tDCS
  • Sham-tDCS

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Association de Recherche Bibliographique pour les Neurosciences

Lead sponsor

Centre Hospitalier Princesse Grace

Collaborator

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

Collaborator