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临床试验/NCT06297538
NCT06297538Unknown不适用

Targeting the Motor Cortex in Parkinson's Disease by Gamma-transcranial Alternating Current Stimulation: Pathophysiological and Therapeutic Implications

Neuromed IRCCS1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年4月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
84
试验地点
1
主要终点
Changes in bradykinesia features as objectively assessed by kinematic techniques

研究概览

简要总结

Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • PD diagnosis

排除标准

  • severe cognitive and psychiatric comorbidities
  • levodopa-induced dyskinesia and tremor-dominant phenotype
  • history of additional neuropsychiatric disorders
  • intake of medications acting on brain excitability or plasticity
  • contraindications to non-invasive brain stimulation

结局指标

主要结局

Changes in bradykinesia features as objectively assessed by kinematic techniques

时间窗: post 5, 15 and 30 minutes

The velocity of finger tapping movements will be kinematically measured and expressed in degrees/second.

Changes in motor learning performance as objectively assessed by kinematic techniques

时间窗: post 5, 15 and 30 minutes

The acceleration peak of finger index abductions will me kinematically measured and expressed as millimeters/seconds

次要结局

未报告次要终点

研究者

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giulia Paparella

Principal Investigator

Neuromed IRCCS

研究点 (1)

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