Clinical trial NCT06860451: To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation
Official title: To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-stroke Depression
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Electroencephalogram
timeFrame: Day 1
measure: Functional near - infrared spectroscopy , fNIRS
timeFrame: Day 1
Secondary outcomes:
measure: Mini-mental state examination,MMSE
timeFrame: Day 1
measure: Montreal Cognitive Assessment, MoCA
timeFrame: Day 1
measure: Hamilton Depression Scale，HAMD
timeFrame: Day 1
measure: Hamilton Anxiety Scale，HAMA
timeFrame: Day 1
measure: Montgomery-Asberg Depression Rating Scale，MADRS
timeFrame: Day 1
measure: Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16
timeFrame: Day 1
measure: Response time
timeFrame: Day 1
measure: Accuracy rates
timeFrame: Day 1
Other outcomes:
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