Deep Brain Stimulation Guided by Brain Recordings for Treatment-Resistant Schizophrenia
Tests brain stimulation, placed using brain recordings, in adults with treatment-resistant schizophrenia.
Plain-language title generated from the registry record
Registry title: SEEG-Guided DBS for Schizophrenia
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07671261, who can take part
Where in China
- Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07671261
- Record updated
- 26 June 2026
- Original description
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.Read full original descriptionShow less
Deep Brain Stimulation for Treatment-Refractory Schizophrenia: Individualized Target Selection and Efficacy
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.
Inclusion: 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: Previous history of stereotactic neurosurgery; 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; 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; Presence of structural brain abnormalities; Contraindications to general anesthesia or stereotactic neurosurgery.