SchizophreniaEPSREAL-SCNCT07176468
Personalized iTBS in Real-World Clinical Settings for Schizophrenia
A study testing Neuronavigation-guided individualized iTBS in people with Schizophrenia and Transcranial Magnetic Stimulation, run by Anhui Medical University at 2 sites in China.
Trial summary
This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Transcranial Magnetic Stimulation
- What is being tested?
- Neuronavigation-guided individualized iTBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2025to 20 Sep 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years, any gender
- Meets DSM-5 criteria for schizophrenia
- Antipsychotic medication change (initiation, dose adjustment, or switch) occurred within the past 3 days
- Capable of understanding the study and providing written informed consent Able to comply with study procedures and complete assessments
Who cannot join
- Active suicidal ideation or behavior
- Major neurological disorders (e.g., epilepsy, organic brain lesions, severe head trauma)
- Contraindications to MRI or TMS (e.g., metal implants, pacemakers)
- Pregnancy or lactation
- Receipt of TMS or ECT within the past 6 months
- Judged by investigators to be unsuitable for participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230000
Gong-Jun Ji, +86-18134516380, 2015500024@ahmu.edu.cn
- Not yet recruiting
Anhui Medical University
Hefei, Anhui, 230032
Kai Wang, PhD, 0551 6516 7581, wangkai1964@126.com
Gong-Jun, PhD, +8618134516380, jigongjun@163.com
About this study
Official title: Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial
This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant.
The main questions it seeks to address are:
Read more
Does the personalized iTBS target TMS protocol improve clinical symptoms in patients with schizophrenia within real-world treatment settings? What neural circuit changes, as assessed by functional MRI, occur following TMS treatment?
Participants will:
Undergo personalized,personalized iTBS target treatment daily for 2 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT).
Have structural and resting-state functional MRI scans before and after treatment.
Be monitored for any treatment-related adverse events.
Read the detailed description
Effective intervention is critical for reducing relapse risk, improving long-term prognosis, and lowering healthcare costs for schizophrenia.The present study therefore aims to assess whether neuronavigation-guided, individualized Intermittent Theta-Burst Stimulation (iTBS) can accelerate symptom improvement in schizophrenia when delivered in real-world clinical settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant. Patients with schizophrenia will be prospectively recruited and received 2 weeks of iTBS treatment.
Before treatment, structural and resting-state functional MRI data wil be collected from each patient. Clinical symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). For patients experiencing auditory verbal hallucinations, the Auditory Hallucination Rating Scale (AHRS) will be also administered. Additionally, a battery of neuropsychological tests will be conducted, including the Montreal Cognitive Assessment (MoCA), Digit Span Test (DST), Verbal Fluency Test (VFT), Stroop Test, and Chinese Auditory Verbal Learning Test (AVLT).
After completing the 2-week iTBS treatment, clinical symptom severity, treatment-related adverse events wil be reassessed.
- Conditions
- Schizophrenia, Transcranial Magnetic Stimulation
- Being tested
- Neuronavigation-guided individualized iTBS
- Keywords
- schizophrenia, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging (fMRI)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuronavigation-guided individualized iTBSOther
Also called iTBS
Participants will receive individualized iTBS for 14 consecutive days in addition to their usual medication regimen.
iTBS parameters: 50 Hz bursts every 200 ms (5 Hz), 2s on/8s off, total 600 pulses per session;6 sessions/day (3 in morning, 3 in afternoon, 3600 pulses/day); 100% RMT intensity; Neuronavigation: Brainsight system (Rogue Research, Canada)
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS) | Experimental | Participants will receive iTBS daily for 2 week within real-world treatment settings Receives: Other: Neuronavigation-guided individualized iTBS |
| Control group: ordinary drug treatment | No intervention | The participants will receive regular medication treatment every day for 2 week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive and Negative Syndrome Scale (PANSS)
The primary outcome was the changes in the Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 2. PANSS total score range 30 to 210, the higher scores indicate more severe symptoms.
Measured: baseline and week 2 (post-treatment)
Secondary outcomes (4)
Positive and Negative Syndrome Scale (PANSS) subscales
Secondary outcomes included changes in the PANSS subscales score. PANSS positive score and negative score range 7 to 49, the higher scores indicate more severe symptoms. PANSS general score range 16 to 112, the higher scores indicate more severe symptoms.
Measured: baseline and week 2 (post-treatment)
Hamilton Anxiety Rating Scale (HAMA)
Secondary outcomes included changes in the HAMA score. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety
Measured: baseline and week 2 (post-treatment)
Hamilton Depression Rating Scale (HAMD)
Secondary outcomes included changes in the HAMD score. HAMA scale scores range from 0 to 50 points, the higher the score indicates the more serious depression.
Measured: baseline and week 2 (post-treatment)
Auditory Hallucination Rating Scale (AHRS)
The changes in the Auditory Hallucination Rating Scale (AHRS) score were also included as a secondary outcome. AHRS range 0 to 41, the higher scores indicate more severe symptoms.
Measured: baseline and week 2 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start20 Oct 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176468
- Sponsor's protocol ID
- AHMU-SCZ-RWTBS
- Acronym
- EPSREAL-SC
- Status last verified
- Dec 2025
- First submitted
- 9 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial
- ClinicalTrials.gov ID
- NCT07176468
- Acronym / sponsor ID
- EPSREAL-SC / AHMU-SCZ-RWTBS
- Conditions
- Schizophrenia, Transcranial Magnetic Stimulation
- Keywords
- schizophrenia, transcranial magnetic stimulation, Functional Magnetic Resonance Imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant.
The main questions it seeks to address are:
Does the personalized iTBS target TMS protocol improve clinical symptoms in patients with schizophrenia within real-world treatment settings? What neural circuit changes, as assessed by functional MRI, occur following TMS treatment?
Participants will:
Undergo personalized,personalized iTBS target treatment daily for 2 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT).
Have structural and resting-state functional MRI scans before and after treatment.
Be monitored for any treatment-related adverse events.
Detailed description
Effective intervention is critical for reducing relapse risk, improving long-term prognosis, and lowering healthcare costs for schizophrenia.The present study therefore aims to assess whether neuronavigation-guided, individualized Intermittent Theta-Burst Stimulation (iTBS) can accelerate symptom improvement in schizophrenia when delivered in real-world clinical settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant. Patients with schizophrenia will be prospectively recruited and received 2 weeks of iTBS treatment.
Before treatment, structural and resting-state functional MRI data wil be collected from each patient. Clinical symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). For patients experiencing auditory verbal hallucinations, the Auditory Hallucination Rating Scale (AHRS) will be also administered. Additionally, a battery of neuropsychological tests will be conducted, including the Montreal Cognitive Assessment (MoCA), Digit Span Test (DST), Verbal Fluency Test (VFT), Stroop Test, and Chinese Auditory Verbal Learning Test (AVLT).
After completing the 2-week iTBS treatment, clinical symptom severity, treatment-related adverse events wil be reassessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS) | Experimental | Other: Neuronavigation-guided individualized iTBSParticipants will receive iTBS daily for 2 week within real-world treatment settings |
| Control group: ordinary drug treatment | No intervention | –The participants will receive regular medication treatment every day for 2 week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-60 years, any gender
- Meets DSM-5 criteria for schizophrenia
- Antipsychotic medication change (initiation, dose adjustment, or switch) occurred within the past 3 days
- Capable of understanding the study and providing written informed consent Able to comply with study procedures and complete assessments
Key exclusion criteria (6 listed)
- Active suicidal ideation or behavior
- Major neurological disorders (e.g., epilepsy, organic brain lesions, severe head trauma)
- Contraindications to MRI or TMS (e.g., metal implants, pacemakers)
- Pregnancy or lactation
- Receipt of TMS or ECT within the past 6 months
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 |
|---|---|---|
| Neuronavigation-guided individualized iTBSAlso: iTBSParticipants will receive individualized iTBS for 14 consecutive days in addition to their usual medication regimen. iTBS parameters: 50 Hz bursts every 200 ms (5 Hz), 2s on/8s off, total 600 pulses per session;6 sessions/day (3 in morning, 3 in afternoon, 3600 pulses/day); 100% RMT intensity; Neuronavigation: Brainsight system (Rogue Research, Canada) | Other | Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS) |
Primary outcome
The Positive and Negative Syndrome Scale (PANSS)
Time frame: baseline and week 2 (post-treatment)
The primary outcome was the changes in the Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 2. PANSS total score range 30 to 210, the higher scores indicate more severe symptoms.
4 secondary outcomes
Positive and Negative Syndrome Scale (PANSS) subscales
Time frame: baseline and week 2 (post-treatment)
Hamilton Anxiety Rating Scale (HAMA)
Time frame: baseline and week 2 (post-treatment)
Hamilton Depression Rating Scale (HAMD)
Time frame: baseline and week 2 (post-treatment)
Auditory Hallucination Rating Scale (AHRS)
Time frame: baseline and week 2 (post-treatment)
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuronavigation-guided individualized iTBS in people with Schizophrenia and Transcranial Magnetic Stimulation, run by Anhui Medical University at 2 sites in China.
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 6 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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 Kai Wang, MD (0551 6516 7581, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive and Negative Syndrome Scale (PANSS) (time frame: baseline and week 2 (post-treatment)). 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 30 Dec 2025.