tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: active-tDCS, Sham-tDCS.
- Who it may be relevant to
- Registry conditions: Lewy Body Dementia, Lewy Body Dementia With Behavioral Disturbance, Burden, Caregiver, Lewy Body Disease. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Monaco
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Device active-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). - Device Sham-tDCS
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).
Primary outcome measures
- Change from Baseline in the composite score named "psychotic factor" at T1 [Time frame: Baseline, Week 2]
- Change from Baseline in the composite score named "psychotic factor" at T2 [Time frame: Baseline, Week 10]
Secondary outcome measures (12)
- Change from Baseline in the Neuropsychiatric Inventory (NPI) total score [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the Zarit scale score [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the Trail Making Test (TMT) A&B performances [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the Quality of life questionnaire (Qol) [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the Mayo Clinic fluctuations scales score [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the percentage of errors during an "antisaccades" paradigm [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the saccades latency (in ms) during an "antisaccades" paradigm [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the frequency of square waves-jerks during horizontal eye movements paradigm [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the frequency of fixations impairments during eye movements paradigm [Time frame: Baseline, Week 2, Week 10]
- Change from Baseline in the saccades main velocity during oculomotor paradigms [Time frame: Baseline, Week 2, Week 10]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Monaco · 1 center
- Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princ — Monaco
Identifiers
NCT: NCT06785948 · MCL-tDCS