Schizo Affective DisorderNCT07621549
Exploring the Feasibility of Transcranial Ultrasound Stimulation in the Treatment of Schizophrenia
A study testing Transcranial Ultrasound Stimulation in people with Schizo Affective Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizo Affective Disorder
- What is being tested?
- Transcranial Ultrasound Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2025to 31 Dec 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
Yi-Ju Pan, Ph. D., 886-2-8966-7000 ext. 2168, panyiju0211@gmail.com
About this study
- 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.
- 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.
- Conditions
- Schizo Affective Disorder
- Being tested
- Transcranial Ultrasound Stimulation
- Keywords
- scizophrenia, TUS, LIPUS
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Ultrasound StimulationDevice
Actual treatment in this group
Transcranial Ultrasound StimulationDevice
No actual treatment in this group
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Transcranial Ultrasound Stimulation |
| pseudotreatment | Placebo comparator | Not described Receives: Device: Transcranial Ultrasound Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Screening phase (4 weeks before the initiation of treatment) in serum concentrations of BDNF at 5(+4) Weeks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Status of neurological examination
Normal or Abnormal
Measured: baseline establishment, and Week 5(+4 weeks)
Height in centimeters
Measured: Screening phase (4 weeks before the initiation of treatment), and Week 5(+4 weeks)
Weight in kilograms
Measured: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Temperature in Celsius
Measured: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Respiratory rate in breaths per minutes
Measured: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Blood pressure in mmHg
Measured: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Electrocardiogram (ECG) R-R interval
Measured: Screening phase (4 weeks before the initiation of treatment) and Week 5(+4 weeks)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizo Affective DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ju Pan, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621549
- Sponsor's protocol ID
- 114029-F
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Transcranial Ultrasound Stimulation in the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT07621549
- Acronym / sponsor ID
- 114029-F
- Conditions
- Schizo Affective Disorder
- Keywords
- scizophrenia, TUS, LIPUS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jun 2026 (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 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcranial Ultrasound Stimulation |
| pseudotreatment | Placebo comparator | Device: Transcranial Ultrasound Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
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 |
|---|---|---|
| Transcranial Ultrasound StimulationActual treatment in this group | Device | Treatment |
| Transcranial Ultrasound StimulationNo actual treatment in this group | Device | pseudotreatment |
Primary outcome
Change 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
Time frame: baseline establishment, and Week 5(+4 weeks)
Normal or Abnormal
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)
4 secondary outcomes
The Positive and Negative Syndrome Scale (PANSS)
Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
Clinical Global Impression (CGI)
Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
Hamilton Depression Rating Scale (HAMD)
Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: baseline establishment, Week 5(+4 weeks), Week 9(+4 weeks), Week 13(+4 weeks)
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 2 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Ultrasound Stimulation in people with Schizo Affective Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Yi-Ju Pan (+2168 886-2-8966-7000, panyiju0211@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change 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)). The study lists 12 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 2 Jun 2026.