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.

NCT06899893 | Not Yet Recruiting

• 1 other identifier: Shen-PJ-Ke-2025-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  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

  From the patient's first treatment to the completion of the 14-day iTBS therapy.

• The Modified Rankin Scale

  From the patient's first treatment to the completion of the 14-day iTBS therapy.

• Hamilton Anxiety Scale

  From the patient's first treatment to the completion of the 14-day iTBS therapy.

• Hamilton Depression Rating Scale

  From the patient's first treatment to the completion of the 14-day iTBS therapy.

• Self-Rating Depression Scale

  From the patient's first treatment to the completion of the 14-day iTBS therapy.

Study Arms (3)

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.

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.

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.

Device: iTBS

Interventions

iTBS DEVICE

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.

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Haotian Wu

CONTACT

+8617861172618; 824918386@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Rehabilitation Medicine, the Second Affiliated Hospital of Kunming Medical University

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share