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
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Speed in the spatial navigation task
研究概览
简要总结
Impairments in spatial memory and spatial navigation are commonly reported amongst patients presenting post-traumatic brain injury (TBI). In this study, the investigators examine the effect of non-invasive deep brain stimulation of the hippocampal-entorhinal complex (HC-EC), a key region supporting navigation abilities, on spatial navigation performance in TBI patients. Using a virtual reality task where participants must first encode and later recall the location of objects in a virtual arena, the investigators contrast performance while active versus control stimulation is applied to the HC-EC. The investigators additionally record brain activity using electroencephalography (EEG) prior to, during, and after task performance to characterize the neural correlates of spatial navigation abilities in TBI patients, and how they are affected by stimulation.
详细描述
Patients will perform a virtual reality spatial navigation task comparable to that used previously by Beanato and colleagues (2024; DOI: 10.1126/sciadv.ado4103). Patients will perform 4 blocks of task, each lasting approximately 10 minutes; during the full duration of each block, either active or control transcranial temporal interference stimulation (tTIS) will be applied in an interleaved manner, and EEG recordings will be collected. Resting-state EEG recordings will also be collected prior to and following task performance.
Structural, diffusion-weighted, and resting-state MRI scans will additionally be performed during a prior baseline session.
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
- •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:
- •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
结局指标
主要结局
Speed in the spatial navigation task
时间窗: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)
Participant speed (in seconds) of departure to, and reach of, object location in the virtual reality spatial navigation task.
Accuracy in the spatial navigation task
时间窗: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)
Accuracy (error, in virtual meters, between correct and recalled object location) in the virtual reality spatial navigation task.
次要结局
- Brain oscillatory activity(Peri-interventional (up to 1 hour; approximate duration of intervention = 40 minutes, administered in a single session))
- Brain structure and connectivity(Baseline (before the intervention))
研究者
Friedhelm Hummel
Professor, Defitech Chair of Clinical Neuroengineering Brain Mind Institute
Ecole Polytechnique Fédérale de Lausanne