NCT06732817

Personalized Dual-target RTMS for Patients with Refractory Schizophrenia

Personalized Repetitive Transcranial Magnetic Stimulation for Patients with Refractory Schizophrenia: an Open-label Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Schizophrenia
• Transcranial Magnetic Stimulation
• Functional Magnetic Resonance Imaging (fMRI)

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-12-13
• Last updated: 2024-12-13

Locations

1 site across 1 country: China