Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre Hospitalier Princesse Grace | OTHER |
| Association des Aidants et Malades à Corps de Lewy (A2MCL) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Active Comparator |
| |
| Sham tDCS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active-tDCS | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin POLET, PhD | Contact | 99995599 | 00377 | kevin.polet@chpg.mc |
| Solange HESSE | Contact | 99995599 | 00377 | solange.hesse@chpg.mc |
| Name | Affiliation | Role |
|---|---|---|
| Sandrine LOUCHART de la CHAPELLE, MD, PhD | Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital | Recruiting | Monaco | 98000 | Monaco |
The specific individual participant data (IPD) sets to be shared would be all IPD that underlie results in a publication
Not provided
the data will become available when summary data are published
We will not share our data publicly, but we may provide it upon reasonable request to the principal investigator or the central contact person.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham-tDCS | Device | 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). |
|
| 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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 | 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. | 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 | 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. | 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. | 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. | Baseline, Week 2, Week 10 |
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided