Clinical trial NCT06785948: tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
Official title: tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lewy Body Dementia
Lewy Body Dementia With Behavioral Disturbance
Burden, Caregiver
Lewy Body Disease
Dementia With Lewy Bodies
Keywords: Transcranial Direct-Current Stimulation (t-DCS)
Brain stimulation
Psychotic symptoms
Caregiver burden
Lead sponsor: Association de Recherche Bibliographique pour les Neurosciences
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Princesse Grace
name: Association des Aidants et Malades à Corps de Lewy (A2MCL)
First posted: 2025-01-21
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Change from Baseline in the composite score named "psychotic factor" at T1
timeFrame: Baseline, Week 2
measure: Change from Baseline in the composite score named "psychotic factor" at T2
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Change from Baseline in the Neuropsychiatric Inventory (NPI) total score
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the Zarit scale score
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the Trail Making Test (TMT) A&B performances
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the Quality of life questionnaire (Qol)
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the Mayo Clinic fluctuations scales score
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the percentage of errors during an "antisaccades" paradigm
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the saccades latency (in ms) during an "antisaccades" paradigm
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the frequency of square waves-jerks during horizontal eye movements paradigm
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the frequency of fixations impairments during eye movements paradigm
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the saccades main velocity during oculomotor paradigms
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the saccades gain during oculomotor paradigms
timeFrame: Baseline, Week 2, Week 10
measure: Change from Baseline in the saccades latency during oculomotor paradigms
timeFrame: Baseline, Week 2, Week 10
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Study officials:
affiliation: Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)
name: Sandrine LOUCHART de la CHAPELLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: