SEEG-guided DBS for Schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial uses stereoelectroencephalography (SEEG) to map brain activity and identify targets for personalized deep brain stimulation (DBS) in adults with treatment-resistant schizophrenia. After SEEG mapping and target verification, participants undergo DBS implantation, followed by optimization of stimulation parameters. The study includes a randomized crossover phase and an open-label treatment period to assess safety and efficacy over 12 months. Primary aims are to determine whether individualized SEEG-guided DBS can reduce psychotic symptoms and improve functioning, while monitoring adverse effects. The design integrates biomarker-driven target selection with iterative stimulation adjustments guided by clinical response.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital, Shanghai JiaoTong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Shuo Ma, PhD
• Email: ms13144@rjh.com.cn
• Phone: 86+15000838003

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.