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临床试验/NCT05542641
NCT05542641已完成不适用

T-mult: Exploring the Impact of TMS Induced Virtual Lesions on the Multimodal Brain Network and Cognition

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Cognitive change

研究概览

简要总结

T-mult is an experimental study using low-frequency (1Hz) single-sesson rTMS to the DLPFC (versus sham rTMS) to explore the effect of virtual lesions on the brain network and cognition in 100 healthy adults (20-65 years old).

研究设计

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

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 20 and 65 years old
  • •Native Dutch speaker
  • •Able to provide written informed consent

排除标准

  • •History of diagnosed neurological or psychiatric disease (including traumatic head injury)
  • •Current and regular use of centrally acting drugs (recreational or prescribed, including analgesics), including the use of alcohol ~8 hours prior to an appointment
  • •Presence of any contraindications for MRI, MEG, or TMS (including resting motor threshold >75% of maximum stimulator output or no useful motor-evoked potential elicitable)
  • •Previous rTMS treatment

研究组 & 干预措施

real rTMS

Experimental

verum rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total

干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)

sham rTMS

Sham Comparator

sham rTMS to the DLPFC, 1500 1Hz pulses at 120% RMT, 25 minutes total

干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)

结局指标

主要结局

Cognitive change

时间窗: baseline versus directly post-intervention (max. 8 weeks after baseline)

Change in performance on a neuropsychological test measuring cognitive functioning in the domain of executive functioning

次要结局

  • Brain network change(baseline versus directly post-intervention (max. 8 weeks after baseline))

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Douw

Associate Professor

Amsterdam UMC, location VUmc

研究点 (1)

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