An interventional study of Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim). in Schizophrenia, Transcranial Magnetic Stimulation and Functional Magnetic Resonance Imaging (fMRI), sponsored by Anhui Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Anhui Medical University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the efficacy of personalized dual-target rTMS for treating patients with refractory schizophrenia and to investigate its underlying neural mechanisms using functional MRI.
The main questions it seeks to address are:
Does the dual-target rTMS protocol improve clinical symptoms in patients with refractory schizophrenia? What neural circuit changes, as assessed by functional MRI, occur following rTMS treatment?
Participants will:
Undergo personalized, dual-target rTMS treatment daily for 3 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.
This open-label clinical trial aimed to evaluate the efficacy and underlying neural mechanisms of a personalized dual-target rTMS protocol for treating patients with refractory schizophrenia. Patients with refractory schizophrenia were prospectively recruited and underwent 3 weeks of rTMS treatment.
Before treatment, structural and resting-state functional MRI data were collected from each patient. Clinical symptom severity was 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) was also administered. Additionally, a battery of neuropsychological tests was 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 3-week rTMS treatment, clinical symptom severity, treatment-related adverse events, and structural and resting-state functional MRI data were reassessed.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Active rTMS was sequentially administered over the left DLPFC and left TPJ sites one hour apart, for 3 weeks.
Device: Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim).
Active rTMS was sequentially administered over the left DLPFC and left TPJ sites one hour apart, for 3 weeks (21 consecutive days), using a transcranial magnetic stimulator (Rapid2; MagStim) with a 70-mm air-cooled figure-of-eight coil. Stimulation at 20 Hz (2 seconds on, 28 seconds off) was applied over the left DLPFC with an intensity set at 100% of the individual resting motor threshold (RMT), delivering a total of 1,600 pulses daily. Continuous theta burst stimulation (cTBS) was applied over the left TPJ at either 100% of the individual RMT or at the highest intensity that the stimulator could deliver for this protocol (50% of maximum output). Three daily sessions of cTBS were administered, separated by two 15-minute breaks, delivering a total of 1,800 pulses daily. The coil was navigated in real-time using a frameless neuro-navigation system (Brainsight; Rogue Research, Montreal, Quebec, Canada).
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 3. PANSS total score range 30 to 210, the higher scores indicate more severe symptoms.
Time frame: baseline and week 3 (post-treatment)
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 3 (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
Time frame: baseline and week 3 (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.
Time frame: baseline and week 3 (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.
Time frame: baseline and week 3 (post-treatment)
Plan to share: No
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Anhui Medical University