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New treatment option for Schizophrenia Disorders
Official title SEEG-Guided DBS for Schizophrenia
ClinicalTrials.gov ID: NCT07671261
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
- Exhibits impaired social functioning, assessed as moderate or severe impairment by the Social and Occupational Functioning Assessment Scale (SOFAS)...
- Has a history of sequential treatment with at least two antipsychotic medications of different chemical structures known for strong how well it works...
You likely can't join if
- 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.
See the full eligibility 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 how well it works against positive symptoms. Treatment must have been at an adequate...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.