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Randomized Controlled Trial of Multi-Target Stereotactic Radiofrequency Thermocoagulation in the Brain for Drug-Refractory Schizophrenia Based on PET/MRI Image Fusion Evidence

Randomized Controlled Trial of Multi-Target Stereotactic Radiofrequency Thermocoagulation in the Brain for Drug-Refractory Schizophrenia Based on PET/MRI Image Fusion Evidence

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128394
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

Traditional Target Group:Implant intracranial electrodes and ablate the traditional targets, the anterior limb of the internal capsule and the claustrum.
Image Fusion Target Group:Combine PET and MRI fusion data to implant intracranial electrodes and ablate the target.
normal imaging control group:MRI, 18F-FDG-PET, 18F-DOPA-PET

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Schizophrenia treatment group: 1. The patient has a diagnosis and a history of formal medication use for more than 3 years, has been treated with clozapine, and meets the criteria for drug-refractory schizophrenia. 2. The patient initially responded well to dopamine receptor blockers but showed poor subsequent response. 3. The patient has paranoid schizophrenia, with symptoms primarily characterized by intermittent auditory or visual hallucinations, and is aged between 18 and 40 years. 4. The patient exhibits normal communication abilities, with no significant impairment in cognitive function or intelligence. 5. The patient demonstrates good treatment compliance, high family cooperation, and strong willingness for treatment from both the patient and family members. According to the regulations of the hospital’s medical ethics committee regarding psychosurgical procedures, the efficacy of the surgery and the risks of complications were explained in detail. Both the patient and family members acknowledged the information provided and signed the informed consent form. Normal imaging control group: Aged 18–40 years; no history of schizophrenia or any other psychiatric disorders; no prior use of psychotropic medications.

Exclusion criteria

Exclusion criteria: Schizophrenia treatment group: 1. Severe impairment in cognitive abilities and intellectual level, language dysfunction, or vision impairment; 2. Presence of violent tendencies or self-harming behaviors; 3. Inability to tolerate surgery due to poor physical condition or other reasons; 4. Conditions such as claustrophobia that prevent cooperation with PET or MRI examinations. Normal imaging control group: Exclusion criteria include abnormal liver and renal function, claustrophobia, implanted metallic devices and other contraindications; subjects shall have indications for PET examination.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale (PANSS) score;Brief Psychiatric Rating Scale (BPRS) score;Clinical Global Impression (CGI) score;Scale for the Assessment of Positive Symptoms (SAPS) score;Scale for the Assessment of Negative Symptoms (SANS) score;

Secondary

MeasureTime frame
Three-Factor Eating Questionnaire (TFEQ) score;Behavioral Activation System - Reward Responsiveness (BAS-R) score;Beck Depression Inventory (BDI) score;Barratt Impulsiveness Scale (BIS-11) score;Modified Overt Aggression Scale (MOAS) score;Launay-Slade Hallucination Scale (LSHS) score;Social Disability Screening Schedule (SDSS) score;Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score;Montreal Cognitive Assessment (MoCA) score;Mini-Mental State Examination (MMSE) score;

Countries

China

Contacts

Public ContactNaili Wei

The First Affiliated Hospital of Shantou University Medical College

nlwei@stu.edu.cn+86 130 6890 7766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026