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Идёт набор NCT06785948

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

Без фазы С лечением Lewy Body Dementia Lewy Body Dementia With Behavioral Disturbance Burden, Caregiver Lewy Body Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: active-tDCS, Sham-tDCS.
Кому может быть актуально
Состояния в реестре: Lewy Body Dementia, Lewy Body Dementia With Behavioral Disturbance, Burden, Caregiver, Lewy Body Disease. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Monaco
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Вмешательства

  • Устройство 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).
  • Устройство 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).

Первичные конечные точки

  • Change from Baseline in the composite score named "psychotic factor" at T1 [Срок оценки: Baseline, Week 2]
  • Change from Baseline in the composite score named "psychotic factor" at T2 [Срок оценки: Baseline, Week 10]
Вторичные конечные точки (12)
  • Change from Baseline in the Neuropsychiatric Inventory (NPI) total score [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the Zarit scale score [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the Trail Making Test (TMT) A&B performances [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the Quality of life questionnaire (Qol) [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the Mayo Clinic fluctuations scales score [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the percentage of errors during an "antisaccades" paradigm [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the saccades latency (in ms) during an "antisaccades" paradigm [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the frequency of square waves-jerks during horizontal eye movements paradigm [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the frequency of fixations impairments during eye movements paradigm [Срок оценки: Baseline, Week 2, Week 10]
  • Change from Baseline in the saccades main velocity during oculomotor paradigms [Срок оценки: Baseline, Week 2, Week 10]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Monaco · 1 центр
  • Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princ — Monaco

Идентификаторы

NCT: NCT06785948 · MCL-tDCS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗