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

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