Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Motor learning performance
研究概览
简要总结
Acute and chronic cognitive impairment (TBI and MCI) is one of the most common problems in the growing and aging society of the 21st century. At an individual level, not all brain structures are affected with the same rate. There are subcortical structures less involved (e.g., the cerebellum), and other more involved (e.g., the hippocampus) in the cognitive decline with age or following a traumatism. To pave the way for personalized precision medicine in the field of cognitive preservation and recovery, there is a need for testing the impact of individually tailored innovative non-invasive neuro-technologies. In this project, we aim at testing the benefit of non-invasively stimulating subcortical structures to boost resilience in supporting motor and non-motor memory.
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
- 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
- 否
入选标准
- •TBI patients:
- •Age ≥ 18 years
- •Clinical diagnosis of TBI
- •No history of other severe neurological or psychiatric disorders
排除标准
- •Unable to consent
- •Severe neuropsychiatric (e.g., major depression, severe dementia) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life threatening infectious diseases)
- •Severe sensory or cognitive impairment or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the experimental tasks
- •Inability to follow or non-compliance with the procedures of the study
- •Contraindications for NIBS or MRI (1):
- •Electronic or ferromagnetic medical implants/device, non-MRI compatible metal implant
- •History of seizures
- •Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics
- •Regular use of narcotic drugs
- •Pregnancy
- •Request of not being informed in case of incidental findings
- •Concomitant participation in another trial involving probing of neuronal plasticity
研究组 & 干预措施
Placebo stimulation
Sham stimulation : ramp-up [5 s] immediately followed by ramp-down [5 s] of high-frequency currents (see Vassiliadis et al., 2023, Nat Hum Behav for more details)
干预措施: transcranial electric stimulation (Other)
Active stimulation
Patterned stimulation (intermittent theta-burst) generating temporal interference in the striatum; see Wessel et al., 2023, Nat Neurosci. for details
干预措施: transcranial electric stimulation (Other)
结局指标
主要结局
Motor learning performance
时间窗: From baseline to 24 hours after training
The primary outcome of the study is the amount of motor learning in a sequential finger-tapping task evaluated during and following training
次要结局
- Brain connectivity(Baseline measure (before the intervention))
研究者
Friedhelm Hummel
Prof. Dr. med.
Ecole Polytechnique Fédérale de Lausanne