NCT06860451Not yet recruiting
To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation
Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 14 Nov 2024
- Start date
- 25 Mar 2025
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Diseases
- Stroke
- NCT number
- NCT06860451
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 25 Mar 2025 to the primary completion date, 30 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
- History of medication use: benzodiazepines, baclofen, antidepressants;
- Acute-phase cerebral hemorrhage, acute infectious diseases;
- Individuals suffering from severe headaches, high blood pressure, malignant tumors, open wounds, vascular embolism, leukopenia, etc.;
- History of cranial surgery, individuals with metal implants in the brain;
- Individuals with an implanted cardiac pacemaker;
- Any disease likely to prevent the patient from surviving more than one month;
Other
- Severe comorbidities;
- Non-compliance with the treatment plan;
- Severe suicidal tendencies in individuals with depression;
- Severe alcohol abuse;
- NIHSS \>26, MMSE \<15;
- Pregnant individuals.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.