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临床试验/NCT06860451
NCT06860451尚未招募不适用

To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation

The Second Affiliated Hospital of Kunming Medical University0 个研究点目标入组 160 人开始时间: 2025年3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
尚未招募
发起方
入组人数
160
主要终点
Electroencephalogram

研究概览

简要总结

Experiment 1: Utilizing a transcranial magnetic stimulation-electroencephalography/functional near-infrared spectroscopy system, the investigators aim to determine whether transcranial magnetic stimulation of the cerebellum can alter neural oscillations and blood flow changes in the prefrontal cortex. The investigators will recruit 80 healthy volunteers and 80 stroke patients with middle cerebral artery infarction, each meeting the inclusion criteria. Twenty healthy volunteers and twenty patients will be randomly selected to receive a single-pulse transcranial magnetic stimulation (TMS) to the cerebellar vermis. The investigators will record cerebellar transcranial evoked potentials (TEP) in the EEG to assess cerebellar cortical excitability and inhibition and evaluate individuals using functional near-infrared spectroscopy to analyze changes in prefrontal blood flow and brain networks. The other 40 healthy volunteers and 40 patients will receive a single-pulse TMS to the right or left cerebellum, and similar assessments will be made. The remaining 20 healthy volunteers and 20 patients will receive a sham iTBS, with similar assessments.

Experiment 2: Through a facial expression recognition task, this experiment aims to clarify the cerebellum's increased perception of negative emotions, thereby achieving a rebalance from "controlled" to "automatic" regulation of negative emotions, ultimately playing a role in "automatic" emotional adjustment. The 80 healthy volunteers from Experiment 1 will be equally divided into four groups based on stimulation site: the cerebellar vermis; the right cerebellum; the left cerebellum; the sham stimulation. Each group will perform the facial expression recognition task during the TMS stimulation. The investigators will collect functional near-infrared spectroscopy and task-based EEG data from the participants during stimulation while also recording their response times, accuracy rates, and completion conditions, including their tolerance of the experiment and any adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Onset of stroke <6 months ago, or >6 months since the last stroke event;
  • •Age >=18 years and <85 years (as the probability of Vascular Cognitive Impairment increases above 85);
  • •Patients with damage in the middle cerebral artery territory;
  • •NIHSS >4 and <26;
  • •mRS score >=2;
  • •Completion of CT or MRI;
  • •No neurological or psychiatric disorders; no impairment of consciousness; able to comply with relevant treatments; no severe cognitive dysfunction (MMSE >=15);
  • •All participants are right-handed; Sign the informed consent form.

排除标准

  • •History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
  • •Severe comorbidities;
  • •History of medication use: benzodiazepines, baclofen, antidepressants;
  • •Non-compliance with the treatment plan;
  • •Acute-phase cerebral hemorrhage, acute infectious diseases;
  • •Severe suicidal tendencies in individuals with depression;
  • •Individuals suffering from severe headaches, high blood pressure, malignant tumors, open wounds, vascular embolism, leukopenia, etc.;
  • •Severe alcohol abuse;
  • •History of cranial surgery, individuals with metal implants in the brain;
  • •Individuals with an implanted cardiac pacemaker;
  • •NIHSS >26, MMSE <15;
  • •Any disease likely to prevent the patient from surviving more than one month;
  • •Pregnant individuals.

研究组 & 干预措施

Left cerebellar intervention group

Experimental

The single-pulse TMS intervention in left cerebellum

干预措施: TMS (Device)

The vermis cerebellar intervention group

Experimental

The single-pulse TMS intervention in vermis cerebellar

干预措施: TMS (Device)

Sham TMS

Sham Comparator

The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration.

干预措施: TMS (Device)

Right cerebellar intervention group

Experimental

The single-pulse TMS intervention in right cerebellum

干预措施: TMS (Device)

结局指标

主要结局

Electroencephalogram

时间窗: Day 1

EEG power in the delta, theta, alpha, beta band: the power spectral density (PSD) in unit\^2/Hz Functional connectivity---Phase locking value (PLV): The value of PLV ranges from 0 to 1 Event related potentials in amplitude/μV

Functional near - infrared spectroscopy , fNIRS

时间窗: Day 1

Hemodynamic curve (HbO) in μM

次要结局

  • Mini-mental state examination,MMSE(Day 1)
  • Montreal Cognitive Assessment, MoCA(Day 1)
  • Hamilton Depression Scale,HAMD(Day 1)
  • Hamilton Anxiety Scale,HAMA(Day 1)
  • Montgomery-Asberg Depression Rating Scale,MADRS(Day 1)
  • Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16(Day 1)
  • Response time(Day 1)
  • Accuracy rates(Day 1)

研究者

发起方
The Second Affiliated Hospital of Kunming Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liqing Yao

Director, Department of Rehabilitation Medicine, the Second Affiliated Hospital of Kunming Medical University

The Second Affiliated Hospital of Kunming Medical University

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