临床试验/NCT04938284

NCT04938284已完成不适用

The Synergistic Effect of Paired Associative Stimulation and Vagus Nerve Stimulation on Motor-evoked Potential Potentiation in Healthy Subjects

Helsinki University Central Hospital1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2021年7月1日最近更新: 2025年5月13日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Helsinki University Central Hospital
入组人数: 10
试验地点: 1
主要终点: Motor evoked potential (MEP) potentiation

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Vagus nerve stimulation (VNS) and paired associative stimulation (PAS) have been shown to have efficacy in improving the results of motor rehabilitation after stroke and spinal cord injury, respectively. Here we will investigate in healthy subjects the synergistic effect of these stimulation modalities on motor-evoked potential (MEP) potentiation.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Exclusion Criteria:
•contraindications to TMS (e.g. brain pathology, implanted devices)
•contraindications to MRI (e.g. MRI incompatible implants)
•continuous use of CNS-active drugs
•neurological, psychiatric or cardiovascular disease
•drug abuse

排除标准

•contraindications to TMS (e.g. brain pathology, implanted devices)
•contraindications to MRI (e.g. MRI incompatible implants)
•continuous use of CNS-active drugs
•neurological, psychiatric or cardiovascular disease
•drug abuse

研究组 & 干预措施

PAS

Active Comparator

干预措施: PAS (Device)

PAS and VNS

Experimental

干预措施: VNS (Device)

VNS

Active Comparator

干预措施: VNS (Device)

PAS and sham VNS

Active Comparator

干预措施: PAS (Device)

PAS and VNS

Experimental

干预措施: PAS (Device)

结局指标

主要结局

Motor evoked potential (MEP) potentiation

时间窗: 90 minutes after the stimulation protocol

MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

Motor evoked potential (MEP) potentiation

时间窗: 0 minutes after the stimulation protocol

MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

Motor evoked potential (MEP) potentiation

时间窗: 30 minutes after the stimulation protocol

MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

Motor evoked potential (MEP) potentiation

时间窗: 60 minutes after the stimulation protocol

MEPs are responses to transcranial magnetic stimulation recorded from target muscles.

次要结局

未报告次要终点

研究者

发起方

Helsinki University Central Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Anastasia Shulga

Head of Department

Helsinki University Central Hospital

研究点 (1)

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