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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-stroke Depression
• Intervention / Treatment: Device: TMS

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yao Zhou; Phone Number: 17752812831; Email: 15608719662@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Right cerebellar intervention group; The single-pulse TMS intervention in right cerebellum	Device: TMS; The single-pulse TMS
Experimental: Left cerebellar intervention group; The single-pulse TMS intervention in left cerebellum	Device: TMS; The single-pulse TMS
Experimental: The vermis cerebellar intervention group; The single-pulse TMS intervention in vermis cerebellar	Device: TMS; The single-pulse TMS
Sham Comparator: Sham TMS; The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration.	Device: TMS; The single-pulse TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalogram	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	Day 1
Functional near - infrared spectroscopy , fNIRS	Hemodynamic curve (HbO) in μM	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-mental state examination,MMSE	Mini-mental state examination,MMSE: A score of 27-30: normal; Score < 27: cognitive impairment.	Day 1
Montreal Cognitive Assessment, MoCA	Montreal Cognitive Assessment, MoCA: The total score of the scale is 30 points, and the test result shows that the normal value is ≥26 points.	Day 1
Hamilton Depression Scale，HAMD	Hamilton Depression Scale，HAMD: A total score of more than 35 May indicate severe depression.	Day 1
Hamilton Anxiety Scale，HAMA	Hamilton Anxiety Scale，HAMA: The total score ≥29, may be severe anxiety; ≥21 points, there must be obvious anxiety; ≥14 points, definitely have anxiety; More than 7 points, may have anxiety; If the score is less than 7, there is no anxiety symptom	Day 1
Montgomery-Asberg Depression Rating Scale，MADRS	Montgomery-Asberg Depression Rating Scale，MADRS: Extreme depression: MADRS >35; Major depression: MADRS >30; Moderate depression: MADRS >22; Mild depression: MADRS >12; Remission stage: MADRS <12.	Day 1
Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16	Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16: The total score is calculated on a scale of 0 to 27, with higher scores being associated with higher levels of depression.	Day 1
Response time	Recording their response times in seconds: The average reaction time of subjects in the facial expression recognition task to judge each facial expression picture.	Day 1
Accuracy rates	Recording their accuracy rates in % during the task: The average correct rate at which subjects judged each expression picture in the facial expression recognition task.	Day 1

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Shen-PJ-Ke-2024-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No