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

NCT06860451 | Not Yet Recruiting

• 1 other identifier: Shen-PJ-Ke-2024-201
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-stroke Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

Study Arms (4)

Right cerebellar intervention group

EXPERIMENTAL

The single-pulse TMS intervention in right cerebellum

Device: TMS

Left cerebellar intervention group

EXPERIMENTAL

The single-pulse TMS intervention in left cerebellum

Device: TMS

The vermis cerebellar intervention group

EXPERIMENTAL

The single-pulse TMS intervention in vermis cerebellar

Device: TMS

Sham TMS

SHAM COMPARATOR

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

Device: TMS

Interventions

TMS DEVICE

The single-pulse TMS

Left cerebellar intervention group; Right cerebellar intervention group; Sham TMS; The vermis cerebellar intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead

Central Study Contacts

Yao Zhou

CONTACT

17752812831; 15608719662@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Rehabilitation Medicine, the Second Affiliated Hospital of Kunming Medical University

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: March 6, 2025
• Study Start: March 25, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share