Individualized Magnetic Stimulation for Post-stroke Cognitive Recovery: Optimization, Validation & Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Change in n-back test performance
研究概览
简要总结
Rationale: 75% of all stroke survivors suffer from cognitive deficits in the acute phase, with serious implications for their long-term quality of life and societal participation. A promising novel therapy is repetitive transcranial magnetic stimulation (rTMS). Only a handful of studies have attempted to promote cognitive functioning after stroke with rTMS. These studies exclusively used a one-size-fits-all approach, which had limited success, as post-stroke cognitive deficits are highly variable. We propose a two-step personalized treatment strategy to identify targets for therapeutic TMS for cognitive rehabilitation after stroke. Step one consits of identification of personalized TMS targets by measuring fMRI activity during a representative cognitive task. In step two, TMS disruption is used to temporarily disrupt activity in the targeted brain region to investigate causal involvement of a brain area in cognitive task performance.
Objective: To validate a proof-of-concept to identify personalized targets for therapeutic TMS for cognitive rehabilitation after stroke.
Study design: A prospective mechanistic intervention study.
Study population: 10 healthy individuals and 15 stroke patients with cognitive impairment
Intervention: Active and sham TMS disruption of personalized targets
Main study endpoints: The n-back test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Age ≥ 18 years;
- •First-ever ischemic stroke or intracerebral haemorrhage in a cerebral hemisphere or the brainstem;
- •Cognitive impairment based on assessment by the treating rehabilitation physician.
- •Able to perform n-back task at inclusion.
- •Inclusion possible within 10 weeks after stroke onset;
- •Signed informed consent.
排除标准
- •Known cognitive impairment prior to stroke onset;
- •Absolute contra-indication to TMS: Magnetic sensitive objects implanted in the head or neck area (e.g. cochlear implants, implanted neurostimulator, pacemaker or defibrillator, metal splinters, metal fragments or metal clips), history of epilepsy, pregnancy or other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;
- •Incompetence or severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits);
- •Life expectancy shorter than one year.
研究组 & 干预措施
Active TMS disruption
Active TMS disruption delivered at 110% RMT
干预措施: Active TMS disruption (Device)
Sham TMS disruption
Active TMS disruption delivered at 20% RMT
干预措施: Sham TMS disruption (Device)
结局指标
主要结局
Change in n-back test performance
时间窗: during TMS disruption
次要结局
未报告次要终点
研究者
Jord Vink
Principal investigator
UMC Utrecht