"Assessment and Treatment of Communicative Pragmatic Abilities in Neurological and Psychiatric Disorders: Feasibility and Clinical Efficacy (PATHS)"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 试验地点
- 6
- 主要终点
- Change in APACS-Brief scores (Assessment of Pragmatic Abilities and Cognitive Substrates - Brief).
研究概览
简要总结
The project goal is to promote a feasible and effective approach to communicative disorders in neurological and psychiatric populations, focused on the pragmatics of language. Pragmatics allows speakers to use and interpret language in context and to engage in successful communication. Pragmatic language disorder is widespread in clinical conditions and causes reduced social interactions and lower quality of life for both patients and their family. Yet it is seldom considered in assessment and rehabilitation.
详细描述
The project aims at developing a comprehensive approach for the assessment and treatment of pragmatic impairment in neurological disease. It consists of three Work Packages:
- The aim of WP1 is to develop a short test of pragmatic abilities. 200 healthy participants will be enrolled for this WP, and the same test will be administered to 40 patients with right hemisphere damage, 40 with traumatic brain injury, and 50 with Schizophrenia.
- The aim of WP2 is to test the efficacy of a novel treatment for pragmatic disorder. 32 patients will be enrolled (16 for each patient group) and allocated (via Randomized Control Trial) to a standard treatment or to a novel treatment for pragmatic disorders. Only RHD and TBI will take part to this WP.
- The aim of WP3 is to better clarify the neural correlates of pragmatic abilities. All patients will undergo an high density EEG recording session, and their brain activity will be correlated with performance on neuropsychological tests and on pragmatic impairment. The RHD and TBI patients enrolled for WP2 will undergo a session of hd-EEG also at the end of rehabilitation to monitor brain changes after treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •no neurological disorder
- •written informed consent Right Hemisphere Damage (RHD)
- •unilateral stroke
- •first stroke
- •no comorbidities with psychiatric disorders
- •written informed consent TBI
- •traumatic brain injury
- •written informed consent
- •Schizophrenia:
- •Diagnosis of Schizophrenia
- •written informed consent
排除标准
- •Important comorbidities that may affect results
研究组 & 干预措施
PRAGMACOM
An experimental treatment for pragmatic disorders characterized by activities that focus on conversational rules and on understanding figurative language. The treatment is already tested on Schizophrenic patients.
干预措施: Pragmatic Rehabilitation (Behavioral)
Standard Neuropsychological Treatment
The standard treatment for neuropsychological disorders is administered to RHD, and TBI patients in the IRCCS San Camillo Hospital, which consists mostly of attentional training.
干预措施: Neuropsychological Rehabilitation (Behavioral)
结局指标
主要结局
Change in APACS-Brief scores (Assessment of Pragmatic Abilities and Cognitive Substrates - Brief).
时间窗: for healthy participants and all patients only t0 (immediatly after enrollment. For patients selected for WP2, T0 (after enrollment, as baseline) and T1 (after the treatment, that is after 1.5 months on average)
A short test on pragmatic abilities. Scores range from 0 to 1. Higher values indicates better score
次要结局
- Change in EEG (Electroencephalography) activity - MMN (Mismatch Negativity)(for healthy participants and all patients only t0 (immediatly after enrollment. For patients selected for WP2, T0 (after enrollment, as baseline) and T1 (after the treatment, that is after 1.5 months on average))
- Change in EEG (Electroencephalography) activity - ASSR (Auditory Steady State Response)(for healthy participants and all patients only t0 (immediatly after enrollment. For patients selected for WP2, T0 (after enrollment, as baseline) and T1 (after the treatment, that is after 1.5 months on average))