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

Association de Recherche Bibliographique pour les Neurosciences

Status

Enrolling

Conditions

Burden, Caregiver

Lewy Body Dementia With Behavioral Disturbance

Lewy Body Dementia

Dementia With Lewy Bodies

Lewy Body Disease

Treatments

Device: active-tDCS

Device: Sham-tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT06785948

MCL-tDCS

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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