An interventional study of active-tDCS and Sham-tDCS in Lewy Body Dementia, Lewy Body Dementia With Behavioral Disturbance and Burden, Caregiver, sponsored by Association de Recherche Bibliographique pour les Neurosciences. Completed at 1 site in Monaco. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Association de Recherche Bibliographique pour les Neurosciences · Not applicable, Interventional, and Treatment
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:
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:
239 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.
This study's enrollment of 21 is below the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Browse Lewy Body Disease studies →Association de Recherche Bibliographique pour les Neurosciences is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: active-tDCS
Device: Sham-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).
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).
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.
Time frame: Baseline, Week 2
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.
Time frame: Baseline, Week 10
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.
Time frame: Baseline, Week 2, Week 10
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.
Time frame: Baseline, Week 2, Week 10
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.
Time frame: Baseline, Week 2, Week 10
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
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the Quality of life questionnaire (Qol)
QoL was measured using the 13-item Quality of Life in Alzheimer's Disease (QOL-AD) scale (total score range 13-52; higher scores indicate better QOL). The QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the Mayo Clinic fluctuations scales score
The Mayo Fluctuations Scale is a four-item questionnaire assessing the common symptoms of cognitive fluctuation shown to significantly differentiate Lewy Body Dementia from Alzheimer disease. These four items are daytime drowsiness, daytime sleepiness, disorganised thought and staring spell. Total score /4.
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the percentage of errors during an "antisaccades" paradigm
Eye movements were recorded and analyzed with an eye-tracking device.
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the saccades latency (in ms) during an "antisaccades" paradigm
Eye movements were recorded and analyzed with an eye-tracking device.
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades
Eye movements are recorded and analyzed with an eye-tracking device. Mean measurement is calculated from several saccades latency recorded during voluntary saccades paradigm
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the frequency of square waves-jerks during horizontal eye movements paradigm
Eye movements are recorded and analyzed with an eye-tracking device. Presence, absence, frequency (number/minute) of square wave-jerks are recorded.
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the frequency of fixations impairments during eye movements paradigm
Eye movements are recorded and analyzed with an eye-tracking device. Presence, absence, frequency of nystagmus, flutters or other fixations impairments
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the saccades main velocity during oculomotor paradigms
This concerns saccades Main velocity (in °/sec) during vertical and horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the saccades gain during oculomotor paradigms
This concerns saccades Gain (gaze accuracy) during vertical and horizontal paradigms. Gain range 0-1. Eye movements were recorded and analyzed with an eye-tracking device.
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the saccades latency during oculomotor paradigms
This concerns saccades Latency (in ms) during vertical and horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.
Time frame: Baseline, Week 2, Week 10
Plan to share: Yes — The specific individual participant data (IPD) sets to be shared would be all IPD that underlie results in a publication
Time frame: the data will become available when summary data are published
Access criteria: We will not share our data publicly, but we may provide it upon reasonable request to the principal investigator or the central contact person.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Association de Recherche Bibliographique pour les Neurosciences