NCT Number: NCT07176468
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Anhui Medical University, Hefei, Anhui, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Other names: iTBS
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.
Time frame: baseline and week 2 (post-treatment)
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)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Gong-Jun Ji, PhD
CONTACT
Kai Wang, MD
CONTACT
Anhui Medical University
Other
Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial
Acronym: EPSREAL-SC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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