SEEG-Guided DBS for Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRuijin Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SEEG implantation
- Deep brain stimulation
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov