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Not yet recruiting NCT06860451

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

No phase Interventional Post-stroke Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TMS.
Who it may be relevant to
Registry conditions: Post-stroke Depression. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device TMS
    The single-pulse TMS

Primary outcome measures

  • Electroencephalogram [Time frame: Day 1]
  • Functional near - infrared spectroscopy , fNIRS [Time frame: Day 1]
Secondary outcome measures (8)
  • Mini-mental state examination,MMSE [Time frame: Day 1]
  • Montreal Cognitive Assessment, MoCA [Time frame: Day 1]
  • Hamilton Depression Scale，HAMD [Time frame: Day 1]
  • Hamilton Anxiety Scale，HAMA [Time frame: Day 1]
  • Montgomery-Asberg Depression Rating Scale，MADRS [Time frame: Day 1]
  • Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16 [Time frame: Day 1]
  • Response time [Time frame: Day 1]
  • Accuracy rates [Time frame: Day 1]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06860451 · Shen-PJ-Ke-2024-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗