NCT07671261Recruiting
SEEG-Guided DBS for Schizophrenia
Deep Brain Stimulation for Treatment-Refractory Schizophrenia: Individualized Target Selection and Efficacy
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 17 Aug 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT07671261
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 17 Aug 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of stereotactic neurosurgery.
Other illness
- 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.
Other
- Presence of structural brain abnormalities.
- Contraindications to general anesthesia or stereotactic neurosurgery.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.