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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Actual treatment in this group
No actual treatment in this group
Far Eastern Memorial Hospital
New Taipei City, Taiwan
RECRUITINGChange from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of BDNF at 5(+4) Weeks.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Status of neurological examination
Normal or Abnormal
Time frame: baseline establishment, and Week 5(+4 weeks)
Height in centimeters
Time frame: Screening phase (4 weeks before the initiation of treatment), and Week 5(+4 weeks)
Weight in kilograms
Time frame: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Temperature in Celsius
Time frame: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Respiratory rate in breaths per minutes
Time frame: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Blood pressure in mmHg
Time frame: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Electrocardiogram (ECG) R-R interval
Time frame: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
The Positive and Negative Syndrome Scale (PANSS)
The Positive and Negative Syndrome Scale (PANSS), developed by Kay et al. in 1987, is a well-established clinical scale utilized to assess symptoms in patients with schizophrenia. The PANSS comprises 30 items categorized into three primary subscales: Positive Scale (7 items): Evaluates pathologically amplified symptoms, such as delusions and hallucinations. Negative Scale (7 items): Focuses on deficit symptoms, including blunted affect and social withdrawal. General Psychopathology Scale (16 items): Covers non-specific psychological states, such as anxiety and tension. Scoring and Clinical Application: Each item is scored on a 7-point severity scale ranging from 1 (absent) to 7 (extreme), yielding a total score between 30 and 210. Characterized by high reliability and validity, the PANSS serves as a critical tool in both clinical research and practice for measuring symptom severity, tracking therapeutic efficacy, and evaluating disease progression.
Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
Clinical Global Impression (CGI)
The Clinical Global Impressions (CGI) scale is a brief, widely accepted instrument used by clinicians to rapidly evaluate psychiatric patients' symptom severity, therapeutic response, and overall efficacy based on direct observation and clinical experience. It comprises three companion subscales: CGI-Severity (CGI-S): Rates the clinician's impression of current illness severity on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). CGI-Improvement (CGI-I): Evaluates overall change relative to the baseline state on a 7-point scale, from 1 (very much improved), 4 (no change), to 7 (very much worse). CGI-Efficacy (CGI-E): Indexes both therapeutic efficacy and treatment-related side effects to gauge global clinical benefit. Due to its simplicity and independence from complex instruments, the CGI is frequently employed in clinical trials and routine practice.
Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
Hamilton Depression Rating Scale (HAMD)
The Hamilton Depression Rating Scale (HAMD), designed by Hamilton in 1960, is a clinical scale used to assess symptom severity in patients with depression. The most widely used version contains 17 items (HAMD-17). Each item is scored 0-4 or 0-2 based on severity. The HAMD-17 ranges from 0 to 52. The HAMD evaluates multiple dimensions, including mood, insomnia, appetite, anxiety, somatic symptoms, and daily functioning. Specific areas assessed include depressed mood, guilt, suicidal ideation, and changes in weight. Total scores indicate illness severity: scores below 7 are generally considered normal, while scores of 20 or higher indicate moderate-to-severe depression. Characterized by high reliability and validity, the HAMD serves as a gold-standard instrument for evaluating the efficacy of antidepressant therapies in clinical trials.
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Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
Cambridge Neuropsychological Test Automated Battery (CANTAB)
The following specific subtests from the Cambridge Neuropsychological Test Automated Battery (CANTAB) will be administered, and individual scores for each task will be systematically recorded: Emotion Recognition Task (ERT): Measures social cognition and emotional processing. Multitasking Test (MTT): Evaluates executive function and cognitive flexibility. One Touch Stockings of Cambridge (OTS): Assesses spatial planning and problem-solving. Paired Associates Learning (PAL): Evaluates visual episodic memory and learning. Reaction Time (RTI): Measures motor and mental response speeds. Rapid Visual Information Processing (RVP): Assesses sustained attention. Spatial Working Memory (SWM): Evaluates working memory and strategy. Verbal Recognition Memory (VRM): Measures immediate and delayed verbal memory.
Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)