跳至主要内容
临床试验/NCT06264063
NCT06264063招募中不适用

Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia

IRCCS Centro Neurolesi "Bonino-Pulejo"2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
2
主要终点
Beck depression inventory

研究概览

简要总结

Dystonias represent hyperkinetic movement disorders characterized by protracted muscle contractions, such as to cause torsional movements and anomalous postures in different parts of the body. Although they occur more often in a focal form (blepharospasm, oromandibular dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck muscles), they are nevertheless capable of significantly influencing the quality of life, with consequent social and health costs. Although described as a predominantly motor disorder, the presence of non-motor symptoms in dystonias associated with alteration of the fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted that the striatum and, more specifically, striatal dopamine, is involved in high cognitive processes such as attention, reward-based learning and decision making. Clinical conditions associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or meso-cortical dopamine transmission also appear to influence temporal estimation, delay discounting, showing an impulsive preference for immediate rewards over delayed gratification.

Based on these premises, the present project aims to evaluate the cognitive and affective aspects of dystonias, in line with neuroimaging research documenting structural and functional dysfunctions in the respective brain regions.

详细描述

Dystonias represent hyperkinetic movement disorders characterized by protracted muscle contractions, such as to cause torsional movements and anomalous postures in different parts of the body. Although they occur more often in a focal form (blepharospasm, oromandibular dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck muscles), they are nevertheless capable of significantly influencing the quality of life, with consequent social and health costs. Although described as a predominantly motor disorder, the presence of non-motor symptoms in dystonias associated with alteration of the fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted that the striatum and, more specifically, striatal dopamine, is involved in high cognitive processes such as attention, reward-based learning and decision making. Clinical conditions associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or meso-cortical dopamine transmission also appear to influence temporal estimation, delay discounting, showing an impulsive preference for immediate rewards over delayed gratification.

Based on these premises, the present project aims to evaluate the cognitive and affective aspects of dystonias, in line with neuroimaging research documenting structural and functional dysfunctions in the respective brain regions.

The study aims to investigate the neurocognitive profile in patients with dystonia. In particular, investigators will evaluate the correlation between the alterations of the subcortical areas and the cognitive and affective functions involved in the processes of evaluating risk, reward and impulsivity.

Primary Objectives:

Study of cognitive and affective functions in dystonic subjects, with particular reference to the mechanisms of reward learning, inhibitory control and impulsivity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years old;
  • Informed consent;
  • Montreal cognitive assessment > 21;

排除标准

  • Patients with cervical dystonia with anterocollis spasm;
  • Sensory-motor deficits that can hinder neuropsychological assessment
  • Contraindications to performing Magnetic Resonance Imaging

研究组 & 干预措施

experimental group

Experimental

patients with dystonia were submitted to a neuropsychological evaluation

干预措施: experimental group (Behavioral)

experimental group

Experimental

patients with dystonia were submitted to a neuropsychological evaluation

干预措施: EEG power in alpha band (Diagnostic Test)

control group

Experimental

healthy patients were submitted to a neuropsychological evaluation

干预措施: control group (Behavioral)

control group

Experimental

healthy patients were submitted to a neuropsychological evaluation

干预措施: EEG power in alpha band (Diagnostic Test)

结局指标

主要结局

Beck depression inventory

时间窗: 1 hour

Study of affective functions in dystonic subjects, with particular reference to the mechanisms of mood and evaluating the presence of depressive symptoms

montreal cognitive assessment

时间窗: 1 hour

Study of cognitive functions in dystonic subjects, with particular reference to the mechanisms of memory, attention and executive functions

次要结局

  • EEG power in alpha band(1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caterina Formica

Principal Investigator

IRCCS Centro Neurolesi "Bonino-Pulejo"

研究点 (2)

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