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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Second Affiliated Hospital of Kunming Medical University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • TMS

    Device

    The single-pulse TMS

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Right cerebellar intervention groupExperimental treatment 1 intervention
Group B: Left cerebellar intervention groupExperimental treatment 1 intervention
Group C: The vermis cerebellar intervention groupExperimental treatment 1 intervention
Group D: Sham TMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1
2

Functional near - infrared spectroscopy , fNIRS

Hemodynamic curve (HbO) in μM

Time frame
Day 1

Secondary outcomes

1

Mini-mental state examination,MMSE

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

Time frame
Day 1
2

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.

Time frame
Day 1
3

Hamilton Depression Scale,HAMD

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

Time frame
Day 1
4

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

Time frame
Day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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