SEEG implantation: Phase 1 involves the stereotactic implantation of Stereoelectroencephalography (SEEG) electrodes. Following implantation, comprehensive electrophysiological monitoring is conducted, including resting-state and task-state recordings, as well as acute electrical stimulation mapping. This process aims to identify the specific pathological neural circuits and electrophysiological biomarkers associated with the patient's individual psychotic symptoms.
Deep brain stimulation: Phase 2 involves individualized deep brain stimulation (DBS). Instead of relying solely on standardized anatomical landmarks, the DBS targets and parameters are precisely customized based on the individualized data acquired during the SEEG mapping phase.
Study summary
This is a prospective, randomized, interventional study designed to evaluate the efficacy and safety of SEEG-guided deep brain stimulation (DBS) for symptom improvement in patients with treatment-resistant schizophrenia. Using stereo-electroencephalography (SEEG) to record brain activity, we will identify specific abnormal electrophysiological targets and signal features associated with clinical symptoms, followed by a 12-month open-label stimulation period. The study is conducted in three stages: Stage 1 consists of SEEG brain mapping, screening of intervention targets, and optimization of stimulation parameters; Stage 2 consists of DBS implantation surgery and further optimization of stimulation parameters; Stage 3 is a randomized crossover treatment phase, followed by an open-label treatment period.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria:
* Meets the International Classification of Diseases, 10th Revision (ICD-10) diagnostic criteria for schizophrenia.
* Male or female, aged 18 to 55 years, with stable vital signs.
* Currently presents with prominent psychotic symptoms, assessed as moderate or severe by the Positive and Negative Syndrome Scale (PANSS) or other equivalent scales.
* Exhibits impaired social functioning, assessed as moderate or severe impairment by the Social and Occupational Functioning Assessment Scale (SOFAS) or other equivalent scales.
* Has a history of sequential treatment with at least two antipsychotic medications of different chemical structures known for strong efficacy against positive symptoms. Treatment must have been at an adequate dose and for an adequate duration (continuous treatment at a therapeutic dose for more than 6 weeks per medication), with good treatment adherence.
* Has been on a stable antipsychotic medication regimen for at least one month prior to enrollment.
* Capable and willing to provide written informed consent.
* Demonstrates good compliance and is able to cooperate with all follow-up procedures.
Exclusion Criteria:
* Diagnosed with any psychiatric disorder other than schizophrenia.
* Presence of a severe personality disorder.
* History of severe neurological diseases, such as seizures or hemorrhagic stroke.
* Presence of structural brain abnormalities.
* Previous history of stereotactic neurosurgery.
* Contraindications to general anesthesia or stereotactic neurosurgery.
* Any current or anticipated condition-including medical, psychological, social, familial support, or geographical factors-that might compromise patient safety or interfere with successful participation in the study.
Primary outcome measure(s)
Reduction Rate of PANSS Positive Subscale or SAPS — Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation. Positive symptoms are assessed using either the Positive and Negative Syndrome Scale (PANSS) positive subscale (P1-P7) or the Scale for the Assessment of Positive Symptoms (SAPS). The PANSS evaluates positive, negative, and general psychopathology symptoms (total score range: 30-210). The SAPS evaluates hallucinations, delusions, bizarre behavior, and positive formal thought disorder. For both scales, higher scores indicate greater symptom severity.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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