Exploring the Feasibility of Transcranial Ultrasound Stimulation in the Treatment of Schizophrenia

Обзор

1. The purpose of this study is to evaluate the safety and feasibility of transcranial ultrasound stimulation (TUS) treatment in patients with schizophrenia. Subjects are individuals diagnosed with schizophrenia who will receive non-invasive, low-intensity pulsed ultrasound stimulation targeting the hippocampus and its surrounding regions. Evaluations will be conducted before and after the treatment sessions, including electrocardiograms (ECG), blood biochemistry tests, psychiatric symptom assessments, depression level assessments, and cognitive function assessments. 2. The primary objective is to assess the safety of this intervention in patients with schizophrenia. The secondary objective is to explore whether the current stimulation parameters may lead to improvements in the assessed symptoms. Ultimately, this study aims to support the future application of low-intensity pulsed ultrasound as a potential intervention to alleviate symptoms of schizophrenia and improve patients' quality of daily life.

Вмешательства

• Устройство Transcranial Ultrasound Stimulation
  Actual treatment in this group
• Устройство Transcranial Ultrasound Stimulation
  No actual treatment in this group

Первичные конечные точки

• Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of BDNF at 5(+4) Weeks. [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]
• Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of IL-1 at 5(+4) Weeks. [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]
• Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of IL-6 at 5(+4) Weeks. [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]
• Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of IL-8 at 5(+4) Weeks. [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]
• Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of TNF-alpha at 5(+4) Weeks. [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]
• Status of neurological examination [Срок оценки: baseline establishment, and Week 5(+4 weeks)]
• Height in centimeters [Срок оценки: Screening phase (4 weeks before the initiation of treatment), and Week 5(+4 weeks)]
• Weight in kilograms [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]
• Temperature in Celsius [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]
• Respiratory rate in breaths per minutes [Срок оценки: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)]

Вторичные конечные точки (4)

• The Positive and Negative Syndrome Scale (PANSS) [Срок оценки: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)]
• Clinical Global Impression (CGI) [Срок оценки: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)]
• Hamilton Depression Rating Scale (HAMD) [Срок оценки: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)]
• Cambridge Neuropsychological Test Automated Battery (CANTAB) [Срок оценки: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)]

Критерии участия

Критерии включения

• Age: 18-65 years old.
• Gender: Both males and females are eligible.
• Diagnosed with schizophrenia according to DSM-V criteria (a PANSS total score of less than approximately 90).
• No changes in medication (same dosage and same drug) for at least one month.

Критерии исключения

• History of head injury with loss of consciousness for more than 10 minutes or a history of brain surgery.
• Any history of epilepsy.
• Presence of a family history of epilepsy
• Heavy alcohol consumption or use of illicit drugs (substance dependence within the last 6 months or substance abuse within the last month).
• Any significant medical conditions that could affect normal brain function (including but not limited to stroke, CNS infections or tumors, or other major neurological diseases).
• Presence of a cardiac pacemaker, implanted medication pump, intracardiac lines, or acute/unstable cardiac disease, as well as intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metallic objects in or near the head (excluding oral metal objects)
• Pregnant or breastfeeding women.
• Presence of suicidal or self-harming tendencies
• Current use of medications known to lower the seizure threshold or increase the risk of suicidal behavior
• Presence of severe and uncontrolled systemic diseases (e.g., heart failure, liver failure, renal failure, vitamin B12 deficiency, hypothyroidism), as determined by the investigator to be unsuitable for study participation
• Patients with uncontrolled diabetic retinopathy accompanied by active fundus hemorrhage
• Concurrent participation in other clinical studies or clinical trials
• Presence of contraindications to the medical devices used in this study (including pulsed ultrasound, EEG, and CT), such as unheindividuals with obvious head trauma, unhealed head surgery, or significant physical or psychiatric symptoms.
• Any other conditions deemed unsuitable for participation in the clinical trial as assessed by the physician.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Far Eastern Memorial Hospital — New Taipei City

Идентификаторы

NCT: NCT07621549 · 114029-F

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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