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NCT Number: NCT06860451

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TMS

Device

The single-pulse TMS

Primary outcomes

  1. Electroencephalogram

    Time frame: 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

  2. Functional near - infrared spectroscopy , fNIRS

    Time frame: Day 1

    Hemodynamic curve (HbO) in μM

Secondary outcomes

  1. Mini-mental state examination,MMSE

    Time frame: Day 1

    Mini-mental state examination,MMSE: A score of 27-30: normal; Score < 27: cognitive impairment.

  2. Montreal Cognitive Assessment, MoCA

    Time frame: Day 1

    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.

  3. Hamilton Depression Scale,HAMD

    Time frame: Day 1

    Hamilton Depression Scale,HAMD: A total score of more than 35 May indicate severe depression.

  4. Hamilton Anxiety Scale,HAMA

    Time frame: Day 1

    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

  5. Montgomery-Asberg Depression Rating Scale,MADRS

    Time frame: Day 1

    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.

  6. Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16

    Time frame: Day 1

    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.

  7. Response time

    Time frame: Day 1

    Recording their response times in seconds: The average reaction time of subjects in the facial expression recognition task to judge each facial expression picture.

  8. Accuracy rates

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yao Zhou

CONTACT

[email protected]

17752812831

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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