Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
研究概览
简要总结
A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. The role of the right hemisphere in recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.
详细描述
The investigators will evaluate, at inclusion and at 6 weeks, the reorganization of functional and structural brain connectivity maps before and after rehabilitation of aphasia with art therapy and standard orthophonic rehabilitation versus a control group that received only standard orthophonic rehabilitation.
The investigators will include all consecutive patients with recent ischemic or hemorrhagic stroke with unilateral lesion(s) of the parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute phase at 24-48h.
All patients will undergo 2 MRI with tensor diffusion sequences (structural connectivity) and fMRI (functional magnetic resonance imaging) resting state sequences (functional connectivity) at inclusion and 6 weeks after rehabilitation with or without art therapy.
The investigators aimed to demonstrate that early activation of the right hemisphere related to the practice of the visual arts could facilitate the recovery of language in later strokes completely disrupting the language areas of the left hemisphere.
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)
盲法说明
Single-blind: only the art therapist knows the randomization arm. The investigators involved in the outcomes assessement, will remain blinded with regard to the randomized treatment assignments
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent ischemic or haemorrhagic stroke with unilateral lesion (s) of the parieto-temporal left junction present on the Diffusion MRI (DWI) performed in acute phase at 24-48h
- •Post stroke delay of 15 days to 2 months
- •Existence of moderate to severe phasic disorders on Aphasia Rapid Test score (ART, score> 6, scale of 26 items)
- •Patient able to read and understand French
- •Normal and corrected vision and hearing
- •Absence of pre-existing degenerative neurological disorder
- •Patient having signed his consent
- •Age ≥ 18 years
排除标准
- •Patients with contraindications to MRI or claustrophobic
- •Patients under legal protection
- •Patients with behavioral disorders or disabling neurovisual disorders making participation in art therapy impossible
- •Mute patients, illiterate patients
- •Patients leaving the neurological SSR department prematurely
- •Patients not affiliated to a social security scheme
- •Pregnant or lactating women.
研究组 & 干预措施
Art therapy
Art therapy and standard orthophonic rehabilitation
干预措施: Art therapy and standard orthophonic rehabilitation (Other)
Control group
Only standard orthophonic rehabilitation
结局指标
主要结局
change from baseline measurement of white substance bundles volumes for structural connectivity at 6 weeks
时间窗: from inclusion at 6 weeks
change from baseline measurement of synchrony amplitude of slow fluctuations for functional Connectivity at 6 weeks
时间窗: from inclusion at 6 weeks
次要结局
- change from baseline Quality of life self-assessment at 6 weeks(from inclusion at 6 weeks)
- change from baseline Anxiety and depression at 6 weeks(from inclusion and at 6 weeks)
- Satisfaction self-assessment at 6 weeks(at 6 weeks only)
- change from baseline Aphasia at 6 weeks(from inclusion at 6 weeks)