Evaluation de l'Effet de la tDCS Sur Les Fonctions Cognitives de Patients Souffrant de Maladie d'Alzheimer et Maladies apparentées au Stade léger
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- change from baseline cognitive functions at 3 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment).
After unblinding, patients who received placebo treatment could be received active tDCS.
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
- Triple (Participant, Care Provider, Investigator)
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
- •National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRADA) criteria (Alzheimer's patient) OR Gordo-Tempini criteria (PPA's patient)
- •CDR score ≤ 2
- •treatment by IAChE ≥ 3 months
- •MADRS score < 18
- •w/o severe progressive somatic pathology (especially tumor diseases)
排除标准
- •last neuropsychological assessment < 6 months
- •presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)
研究组 & 干预措施
anodal tDCS on left DLPFC (F3)
tDCS is a non-invasive neuromodulation method, which delivers a constant current of low intensity (1 mA) during 30 minutes for 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
sham tDCS on left DLPFC (F3)
Sham tDCS differs from active tDCS by the interruption of stimulation after 15 sec and reactivation of the stimulation 15 sec before the end of the session (30 minutes - 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair.
干预措施: transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
change from baseline cognitive functions at 3 weeks
时间窗: baseline, day 5 and 3 weeks post-tDCS
neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)
次要结局
未报告次要终点