The Effects of a Multimodal Approach for the Treatment of Primary Progressive Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in naming test scores on Picture Naming Task
研究概览
简要总结
Primary Progressive Aphasia (PPA) is an untreatable neurodegenerative disorder that disrupts language functions. Available therapies are mainly symptomatic and recently attention has been gained by new techniques that allow for noninvasive brain stimulation such as transcranial direct current stimulation (tDCS). The primary objective of this study is to evaluate whether the application of Active tDCS (anode over the left dorsolateral prefrontal cortex- DLPFC with the cathode over the right supraorbital region) to the scalp during individualized language training, would improve naming abilities in the agrammatic variant of PPA (avPPA) more than use of one methodology alone. The effect of treatment on the clinical symptoms will be related to changes in brain activity (Magnetic Resonance Imaging, MRI and Functional near-infrared spectroscopy fNIRS) and in biological markers, using a multimodal approach. Finally, we will assess the long-term effects of this approach.
详细描述
45 patients with avPPA, will be recruited from IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy and ASST Spedali Civili Brescia, Italy .
Inclusion criteria will be a diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011) and a FTD Clinical Dementia Rating score >0.5 and <2. Exclusion criteria will be the presence of any medical or psychiatric illness that could interfere in completing assessments and the presence of any medical condition that represents a contraindication to tDCS. All the patients will undergo five consecutive days a week for two weeks of treatment sessions:
15 patients will receive Active tDCS over DLPFC while performing a language training; 15 patients will receive placebo tDCS during language training; 15 patients will receive Active tDCS over DLPFC during unstructured cognitive training.
Two trained neuropsychologists will administer the neuropsychological testing in two sessions. At baseline (T0), post-treatment (T1) and 3-months (T2) follow-up assessments were conducted by the same assessor. Blood sample withdrawal at baseline (T0) and after the DLPFC-tDCS intervention (T1) will be assessed.
To elucidate the mechanisms underlying tDCS effects, structural imaging, functional connectivity (fMRI) alterations and concentration changes of hemoglobin (fNIRS) will be collected off-line. Each avPPA patient will undergo an MRI scan at the ASST Spedali Civili Brescia, Italy at T0 and T1 and a fNIRS acquisition at the IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy at T0, T1 and T2.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011)
- •FTD Clinical Dementia Rating (FTD-CDR) score >0.5 and <2
排除标准
- •Presence of any medical or psychiatric illness that could interfere in completing assessments
- •Presence of any medical condition that represents a contraindication to tDCS.
研究组 & 干预措施
Active tDCS plus individual language training
Active tDCS plus individual language training
干预措施: Active tDCS (Device)
Active tDCS plus individual language training
Active tDCS plus individual language training
干预措施: Language training (Behavioral)
placebo tDCS plus individual language training
placebo tDCS plus individual language training
干预措施: Placebo tDCS (Device)
placebo tDCS plus individual language training
placebo tDCS plus individual language training
干预措施: Language training (Behavioral)
Active tDCS plus unstructured cognitive stimulation
Active tDCS plus unstructured cognitive stimulation
干预措施: Active tDCS (Device)
Active tDCS plus unstructured cognitive stimulation
Active tDCS plus unstructured cognitive stimulation
干预措施: Unstructured cognitive training (Behavioral)
结局指标
主要结局
Change in naming test scores on Picture Naming Task
时间窗: Baseline up to 2 weeks and 3 months
Picture Naming Task: percentage of correct responses (0-100)
次要结局
- Change in quality of life on Stroke and Aphasia Quality of Life(Baseline up to 2 weeks and 3 months)
- Change in dementia severity on Frontotemporal Dementia-modified Clinical Dementia Rating Scale(Baseline up to 2 weeks and 3 months)
- Change in cognitive impairment on Mini Mental State Examination(Baseline up to 2 weeks and 3 months)
- Change in constructional praxia on Rey-Osterrieth Complex Figure-Copy(Baseline up to 2 weeks and 3 months)
- Change in aphasia severity on Screening for Neurodegenerative Aphasia(Baseline up to 2 weeks and 3 months)
- Change in naming on naming subtest from Aachener Aphasie Test(Baseline up to 2 weeks and 3 months)
- Change in molecular biomarkers on neurogranin(Baseline up to 2 weeks)
- Change in imaging biomarkers on fMRI and fNIRS(Baseline up to 2 weeks)
- Change in verbal long term memory on Story Recall(Baseline up to 2 weeks and 3 months)
- Change in nonverbal long term memory on Rey-Osterrieth Complex Figure-Recall(Baseline up to 2 weeks and 3 months)
- Change in fluency abilities on Verbal Fluency (semantic and phonemic)(Baseline up to 2 weeks and 3 months)
- Change in attentional abilities on Trial Making Test(Baseline up to 2 weeks and 3 months)
- Change in language impairment on Mini Language State Examination(Baseline up to 2 weeks and 3 months)