Personalized Dual-target RTMS for Patients with Refractory Schizophrenia

NCT06732817 | Completed

• 1 other identifier: AHMU-TMS-SCZ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

schizophrenia; transcranial magnetic stimulation; dual-target

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and week 3 (post-treatment)

Secondary Outcomes (4)

• Positive and Negative Syndrome Scale (PANSS) subscales

  baseline and week 3 (post-treatment)

• Hamilton Anxiety Rating Scale (HAMA)

  baseline and week 3 (post-treatment)

• Hamilton Depression Rating Scale (HAMD)

  baseline and week 3 (post-treatment)

• Auditory Hallucination Rating Scale (AHRS)

  baseline and week 3 (post-treatment)

Study Arms (1)

Personalized dual-target active rTMS treatment

ACTIVE COMPARATOR

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).

Interventions

Active rTMS was administered using a transcranial magnetic stimulator (Rapid2; MagStim). DEVICE

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).

Personalized dual-target active rTMS treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed by independent psychiatrists using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition;
• disease duration longer than six years;
• hospitalization two or more times;
• aged 18-60 years;

You may not qualify if:

• accompanied by other mental illnesses or histories;
• pregnant;
• a history of severe head trauma or neurological disease;
• focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery MRI;
• a history of rTMS or electroconvulsive therapy in the six months prior to the study; and
• metal objects in the head or any other contraindication to MRI.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: April 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)