Post-stroke DepressionNCT06860451
To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation
A study testing TMS in people with Post-stroke Depression, run by The Second Affiliated Hospital of Kunming Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
The single-pulse TMS
| Study group | Role | What they receive |
|---|---|---|
| Right cerebellar intervention group | Experimental | The single-pulse TMS intervention in right cerebellum Receives: Device: TMS |
| Left cerebellar intervention group | Experimental | The single-pulse TMS intervention in left cerebellum Receives: Device: TMS |
| The vermis cerebellar intervention group | Experimental | The single-pulse TMS intervention in vermis cerebellar Receives: Device: TMS |
| Sham TMS | Sham comparator | The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Functional near - infrared spectroscopy , fNIRS
Hemodynamic curve (HbO) in μM
Measured: Day 1
Secondary outcomes (8)
Mini-mental state examination,MMSE
Mini-mental state examination,MMSE: A score of 27-30: normal; Score < 27: cognitive impairment.
Measured: Day 1
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.
Measured: Day 1
Hamilton Depression Scale，HAMD
Hamilton Depression Scale，HAMD: A total score of more than 35 May indicate severe depression.
Measured: Day 1
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
Measured: Day 1
Montgomery-Asberg Depression Rating Scale，MADRS
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.
Measured: Day 1
Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16
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.
Measured: Day 1
Response time
Recording their response times in seconds: The average reaction time of subjects in the facial expression recognition task to judge each facial expression picture.
Measured: Day 1
Accuracy rates
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liqing Yao, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860451
- Sponsor's protocol ID
- Shen-PJ-Ke-2024-201
- Status last verified
- Mar 2025
- First submitted
- 14 Nov 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT06860451
- Acronym / sponsor ID
- Shen-PJ-Ke-2024-201
- Conditions
- Post-stroke Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Right cerebellar intervention group | Experimental | Device: TMSThe single-pulse TMS intervention in right cerebellum |
| Left cerebellar intervention group | Experimental | Device: TMSThe single-pulse TMS intervention in left cerebellum |
| The vermis cerebellar intervention group | Experimental | Device: TMSThe single-pulse TMS intervention in vermis cerebellar |
| Sham TMS | Sham comparator | Device: TMSThe TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSThe single-pulse TMS | Device | Left cerebellar intervention group, Right cerebellar intervention group, Sham TMS, The vermis cerebellar intervention group |
Primary outcome
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
Functional near - infrared spectroscopy , fNIRS
Time frame: Day 1
Hemodynamic curve (HbO) in μM
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Post-stroke Depression, run by The Second Affiliated Hospital of Kunming Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Zhou (17752812831, 15608719662@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.