StrokeNCT06899893
The Research Team Aims to Elucidate the Impact of ITBS (intermittent Theta Burst Stimulation) on the HPA Axis and Post-stroke Negative Emotions/depression by Conducting Human Experiments That Target Various Brain Regions.
A study testing iTBS in people with Stroke and Post-stroke Depression, run by The Second Affiliated Hospital of Kunming Medical University.
Trial summary
The project team will categorize stroke patients into three groups receiving iTBS stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (DLPFC), and the primary motor cortex (M1), with 20 patients allocated to each group. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Post-stroke Depression
- What is being tested?
- iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 30 Jul 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Initial stroke onset <6 months, or the last stroke event occurred more than 6 months ago;
- Age ≥18 years, <85 years (the likelihood of VCI increases beyond 85 years);
- Patients with lesions in the middle cerebral artery region;
- NIHSS >4, NIHSS <26;
- mRS score ≥2;
- Completion of CT or MRI;
Show all 9Show fewer
- No severe neurological or psychiatric disorders; no impairment of consciousness, able to cooperate with relevant treatments; no severe cognitive impairment (MMSE ≥15);
- All participants are right-handed;
- Signed 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, or antidepressants;
- Non-compliance with the protocol;
- Acute phase of cerebral hemorrhage or acute infectious diseases;
- Severe suicidal tendencies in patients with depression;
Show all 13Show fewer
- Severe headache, hypertension, malignant tumors, open wounds, vascular embolism, leukopenia, or other serious conditions;
- Severe alcohol abuse;
- History of cranial surgery or presence of metal implants in the brain;
- Patients with cardiac pacemakers;
- NIHSS > 26 or MMSE < 15;
- Any condition likely to result in the patient's survival for less than 1 month;
- Pregnancy.
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
Official title: Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.
The project team will categorize stroke patients into three groups receiving iTBS stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (DLPFC), and the primary motor cortex (M1), with 20 patients allocated to each group. Neurofunctional scores, anxiety and depression assessments, and transcranial magnetic stimulation evoked potentials (TEP) will be assessed pre- and post-treatment within each group. The relationship between anxiety and depression scores and brain network characteristics associated with emotions will be examined to investigate the impact of iTBS stimulation on post-stroke negative emotions. Furthermore, plasma and saliva samples will be collected from stroke patients in each group post iTBS intervention. ELISA will quantify ACTH levels in plasma and cortisol levels in both plasma and saliva, with the aim of exploring the effects of iTBS stimulation on the HPA axis across different brain regions.
- Conditions
- Stroke, Post-stroke Depression
- Being tested
- iTBS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBSDevice
Sixty patients experiencing post-stroke negative emotions were recruited and categorized into groups based on their conditions. The group with post-stroke balance dysfunction underwent intermittent theta burst stimulation (iTBS) of the cerebellum, while the group with post-stroke cognitive dysfunction received iTBS stimulation of the left dorsolateral prefrontal cortex (DLPFC), and the group with post-stroke motor dysfunction underwent iTBS stimulation of the primary motor cortex (M1).The TMS stimulation protocol consisted of 20-minute sessions, five times a week, for a total of ten sessions, utilizing a figure-of-eight coil (model B9076, coil diameter 92 mm, manufactured by Yiruide Company in Wuhan, China, transcranial magnetic therapy device model NS5000). The stimulation intensity was set at 80% of the active motor threshold, with the coil positioned tangentially to the scalp and the handle oriented upwards.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation of the cerebellar group using iTBS. | Experimental | In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS cerebellar stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes. Receives: Device: iTBS |
| Stimulation of the Left Dorsolateral Prefrontal Cortex group using iTBS. | Experimental | In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Left Dorsolateral Prefrontal Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes. Receives: Device: iTBS |
| Stimulation of the Primary Motor Cortex (M1) group using iTBS. | Experimental | In the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Primary Motor Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes. Receives: Device: iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol
Saliva samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify cortisol levels in saliva. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of cortisol in saliva is measured in nanograms per milliliter (ng/mL).
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Plasma adrenocorticotropic hormone
Plasma samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify ACTH levels in plasma. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of ACTH in plasma is measured in picograms per milliliter (pg/mL).
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Plasma cortisol
Plasma samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify cortisol levels in plasma. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of cortisol in plasma is measured in nanograms per milliliter (ng/mL).
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Secondary outcomes (6)
The National Institutes of Health Stroke Scale
The NIHSS ranges from 0 (no stroke symptoms) to 42 (most severe stroke), with higher scores indicating worse outcomes and lower scores indicating better outcomes.
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
The Modified Rankin Scale
The Modified Rankin Scale (mRS) ranges from 0 (no symptoms) to 6 (death), with higher scores indicating worse outcomes.
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAM-A) ranges from 0 (no anxiety) to 56 (severe anxiety), with higher scores indicating worse outcomes.
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HDRS) ranges from 0 (no depression) to 52 (severe depression), with higher scores indicating worse outcomes.
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Self-Rating Depression Scale
The Self-Rating Depression Scale (SDS) ranges from 20 (no depression) to 80 (severe depression), with higher scores indicating worse outcomes.
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Self-Rating Anxiety Scale
The Self-Rating Anxiety Scale (SAS) ranges from 20 (no anxiety) to 80 (severe anxiety), with higher scores indicating worse outcomes.
Measured: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 60 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
- NCT06899893
- Sponsor's protocol ID
- Shen-PJ-Ke-2025-1
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2025
- Last updated
- 28 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.
- ClinicalTrials.gov ID
- NCT06899893
- Acronym / sponsor ID
- Shen-PJ-Ke-2025-1
- Conditions
- Stroke, Post-stroke Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 28 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.
The project team will categorize stroke patients into three groups receiving iTBS stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (DLPFC), and the primary motor cortex (M1), with 20 patients allocated to each group. Neurofunctional scores, anxiety and depression assessments, and transcranial magnetic stimulation evoked potentials (TEP) will be assessed pre- and post-treatment within each group. The relationship between anxiety and depression scores and brain network characteristics associated with emotions will be examined to investigate the impact of iTBS stimulation on post-stroke negative emotions. Furthermore, plasma and saliva samples will be collected from stroke patients in each group post iTBS intervention. ELISA will quantify ACTH levels in plasma and cortisol levels in both plasma and saliva, with the aim of exploring the effects of iTBS stimulation on the HPA axis across different brain regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stimulation of the cerebellar group using iTBS. | Experimental | Device: iTBSIn the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS cerebellar stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes. |
| Stimulation of the Left Dorsolateral Prefrontal Cortex group using iTBS. | Experimental | Device: iTBSIn the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Left Dorsolateral Prefrontal Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes. |
| Stimulation of the Primary Motor Cortex (M1) group using iTBS. | Experimental | Device: iTBSIn the trial, the group is anticipated to enroll 20 patients with post-stroke balance dysfunction for iTBS Primary Motor Cortex stimulation.At the outset of enrollment (T0 phase), peripheral blood and saliva samples must be obtained to assess HPA axis-related indicators and to evaluate brain networks using TMS. Following the 15-day treatment period (T1 phase), the aforementioned blood samples will be collected once more for further testing. Furthermore, any adverse events will be documented, encompassing secondary cardiovascular events, epilepsy, and mortality outcomes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Initial stroke onset <6 months, or the last stroke event occurred more than 6 months ago;
- Age ≥18 years, <85 years (the likelihood of VCI increases beyond 85 years);
- Patients with lesions in the middle cerebral artery region;
- NIHSS >4, NIHSS <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, or antidepressants;
- Non-compliance with the protocol;
- Acute phase of cerebral hemorrhage or 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 |
|---|---|---|
| iTBSSixty patients experiencing post-stroke negative emotions were recruited and categorized into groups based on their conditions. The group with post-stroke balance dysfunction underwent intermittent theta burst stimulation (iTBS) of the cerebellum, while the group with post-stroke cognitive dysfunction received iTBS stimulation of the left dorsolateral prefrontal cortex (DLPFC), and the group with post-stroke motor dysfunction underwent iTBS stimulation of the primary motor cortex (M1).The TMS stimulation protocol consisted of 20-minute sessions, five times a week, for a total of ten sessions, utilizing a figure-of-eight coil (model B9076, coil diameter 92 mm, manufactured by Yiruide Company in Wuhan, China, transcranial magnetic therapy device model NS5000). The stimulation intensity was set at 80% of the active motor threshold, with the coil positioned tangentially to the scalp and the handle oriented upwards. | Device | Stimulation of the Left Dorsolateral Prefrontal Cortex group using iTBS., Stimulation of the Primary Motor Cortex (M1) group using iTBS., Stimulation of the cerebellar group using iTBS. |
Primary outcome
Salivary Cortisol
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Saliva samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify cortisol levels in saliva. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of cortisol in saliva is measured in nanograms per milliliter (ng/mL).
Plasma adrenocorticotropic hormone
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Plasma samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify ACTH levels in plasma. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of ACTH in plasma is measured in picograms per milliliter (pg/mL).
Plasma cortisol
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Plasma samples were collected from stroke patients in each group post-iTBS intervention. These samples were analyzed using ELISA to quantify cortisol levels in plasma. The aim was to explore the impact of iTBS stimulation on various brain regions on the HPA axis. The concentration of cortisol in plasma is measured in nanograms per milliliter (ng/mL).
6 secondary outcomes
The National Institutes of Health Stroke Scale
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
The Modified Rankin Scale
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Hamilton Anxiety Scale
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Hamilton Depression Rating Scale
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Self-Rating Depression Scale
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
Self-Rating Anxiety Scale
Time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.
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 28 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 iTBS in people with Stroke and 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 9 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 28 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. 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 Haotian Wu (+8617861172618, 824918386@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol (time frame: From the patient's first treatment to the completion of the 14-day iTBS therapy.). The study lists 3 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 28 Mar 2025.