NCT06785948招募中不适用
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
Association de Recherche Bibliographique pour les Neurosciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline in the composite score named "psychotic factor" at T1
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from Baseline in the composite score named "psychotic factor" at T1
时间窗: Baseline, Week 2
"psychotic factor" corresponds to the sum of the subscores of psychotic-like symptoms from the Neuropsychiatric Inventory (NPI), namely Delusions, Hallucination, and Agitation/Aggression.
Change from Baseline in the composite score named "psychotic factor" at T2
时间窗: Baseline, Week 10
"psychotic factor" corresponds to the sum of the subscores of psychotic-like symptoms of the Neuropsychiatric Inventory (NPI), namely Delusions, Hallucination, and Agitation/Aggression.
次要结局
- Change from Baseline in the Neuropsychiatric Inventory (NPI) total score(Baseline, Week 2, Week 10)
- Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores(Baseline, Week 2, Week 10)
- Change from Baseline in the Zarit scale score(Baseline, Week 2, Week 10)
- Change from Baseline in the Trail Making Test (TMT) A&B performances(Baseline, Week 2, Week 10)
- Change from Baseline in the Quality of life questionnaire (Qol)(Baseline, Week 2, Week 10)
- Change from Baseline in the Mayo Clinic fluctuations scales score(Baseline, Week 2, Week 10)
- Change from Baseline in the percentage of errors during an "antisaccades" paradigm(Baseline, Week 2, Week 10)
- Change from Baseline in the saccades latency (in ms) during an "antisaccades" paradigm(Baseline, Week 2, Week 10)
- Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades(Baseline, Week 2, Week 10)
- Change from Baseline in the frequency of square waves-jerks during horizontal eye movements paradigm(Baseline, Week 2, Week 10)
- Change from Baseline in the frequency of fixations impairments during eye movements paradigm(Baseline, Week 2, Week 10)
- Change from Baseline in the saccades main velocity during oculomotor paradigms(Baseline, Week 2, Week 10)
- Change from Baseline in the saccades gain during oculomotor paradigms(Baseline, Week 2, Week 10)
- Change from Baseline in the saccades latency during oculomotor paradigms(Baseline, Week 2, Week 10)
研究者
研究点 (2)
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