Personalized iTBS in Real-World Clinical Settings for Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAnhui Medical University
About this 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:
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neuronavigation-guided individualized iTBS
Other interventionParticipants 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)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental:Neuronavigation-guided individualized intermittent theta burst stimulation (iTBS)Experimental treatment 1 intervention
Group B: Control group: ordinary drug treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline and week 2 (post-treatment)Secondary outcomes
1
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.
Time frame
baseline and week 2 (post-treatment)2
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
Time frame
baseline and week 2 (post-treatment)3
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.
Time frame
baseline and week 2 (post-treatment)4
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.
Time frame
baseline and week 2 (post-treatment)Sponsors and contacts
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Source ClinicalTrials.gov