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NCT Number: NCT06899893

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.

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Post-stroke Depression Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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 NIHSS ranges from 0 (no stroke symptoms) to 42 (most severe stroke), with higher scores indicating worse outcomes and lower scores indicating better outcomes.

  2. The Modified Rankin Scale

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

    The Modified Rankin Scale (mRS) ranges from 0 (no symptoms) to 6 (death), with higher scores indicating worse outcomes.

  3. Hamilton Anxiety Scale

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

    The Hamilton Anxiety Scale (HAM-A) ranges from 0 (no anxiety) to 56 (severe anxiety), with higher scores indicating worse outcomes.

  4. Hamilton Depression Rating Scale

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

    The Hamilton Depression Rating Scale (HDRS) ranges from 0 (no depression) to 52 (severe depression), with higher scores indicating worse outcomes.

  5. Self-Rating Depression Scale

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

    The Self-Rating Depression Scale (SDS) ranges from 20 (no depression) to 80 (severe depression), with higher scores indicating worse outcomes.

  6. Self-Rating Anxiety Scale

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

    The Self-Rating Anxiety Scale (SAS) ranges from 20 (no anxiety) to 80 (severe anxiety), with higher scores indicating worse outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Haotian Wu

CONTACT

[email protected]

+8617861172618

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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