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).
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,
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,
Parallel
active-tDCS
Device2mA 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).
Sham-tDCS
DeviceNo 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).
Change from Baseline in the composite score named "psychotic factor" at T1
"psychotic factor" corresponds to the sum of the subscores of psychotic-like symptoms from the Neuropsychiatric Inventory (NPI), namely Delusions, Hallucination, and Agitation/Aggression.
Change from Baseline in the composite score named "psychotic factor" at T2
"psychotic factor" corresponds to the sum of the subscores of psychotic-like symptoms of the Neuropsychiatric Inventory (NPI), namely Delusions, Hallucination, and Agitation/Aggression.
Change from Baseline in the Neuropsychiatric Inventory (NPI) total score
Neuropsychiatric Inventory (NPI), a scale that includes ten behavioral items (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability and aberrant motor behaviors) and two neurovegetative symptoms (sleep and appetite disorders). The evaluation was based on an interview with patients' primary caregivers. Both the frequency (/4) and the severity (/3) of each behavior were determined and a score was calculated by multiplying the frequency and the severity of each behavior observed.
Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores
Neuropsychiatric Inventory (NPI) scale includes ten behavioral items (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability and aberrant motor behaviors) and two neurovegetative symptoms (sleep and appetite disorders). For each behavior the frequency (/4) and the severity (/3) were determined, corresponding to a subscore.
Change from Baseline in the Zarit scale score
The burden of the family caregiver was measured with the Zarit burden interview scale (completed by the caregiver). Composed of 22 questions on the physical, emotional and financial load felt. Total score /88.
Change from Baseline in the Trail Making Test (TMT) A&B performances
The TMT A\&B is a task requiring a subject to connect a sequence of 25 consecutive targets on a sheet of paper, in the shortest time possible without lifting the pen from the paper. Performances are time and number of errors
Click on the lead sponsor to view all of their trials.
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