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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SEEG implantation
Procedure/SurgeryPhase 1 involves the stereotactic implantation of Stereoelectroencephalography (SEEG) electrodes. Following implantation, comprehensive electrophysiological monitoring is conducted, including resting-state and task-state recordings, as well as acute electrical stimulation mapping. This process aims to identify the specific pathological neural circuits and electrophysiological biomarkers associated with the patient's individual psychotic symptoms.
Deep brain stimulation
DevicePhase 2 involves individualized deep brain stimulation (DBS). Instead of relying solely on standardized anatomical landmarks, the DBS targets and parameters are precisely customized based on the individualized data acquired during the SEEG mapping phase.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Stim ON-OFFActive comparator 2 interventions
Group B: Stim OFF-ONPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Reduction Rate of PANSS Positive Subscale or SAPS
Positive symptoms are assessed using either the Positive and Negative Syndrome Scale (PANSS) positive subscale (P1-P7) or the Scale for the Assessment of Positive Symptoms (SAPS). The PANSS evaluates positive, negative, and general psychopathology symptoms (total score range: 30-210). The SAPS evaluates hallucinations, delusions, bizarre behavior, and positive formal thought disorder. For both scales, higher scores indicate greater symptom severity.
Time frame
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.Secondary outcomes
1
Reduction Rate of Auditory Hallucinations (Assessed by PSYRATS-AH)
The severity of auditory hallucinations is assessed using the Psychotic Symptom Rating Scales - Auditory Hallucinations subscale (PSYRATS-AH). Higher scores indicate greater symptom severity.
Time frame
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.2
Reduction Rate of Delusions (Assessed by PSYRATS-D)
The severity of delusions is assessed using the Psychotic Symptom Rating Scales - Delusions subscale (PSYRATS-D). Higher scores indicate greater symptom severity.
Time frame
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.3
Reduction Rate of Depressive Symptoms (Assessed by HAMD)
The severity of depression is assessed using the Hamilton Depression Rating Scale (HAMD). Higher scores indicate greater severity of depressive symptoms. The reduction rate will be calculated based on the change in the HAMD total score from baseline to each follow-up time point.
Time frame
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.4
Reduction Rate of Anxiety Symptoms (Assessed by HAMA)
The severity of anxiety is assessed using the Hamilton Anxiety Rating Scale (HAMA). Higher scores indicate greater severity of anxiety symptoms. The reduction rate will be calculated based on the change in the HAMA total score from baseline to each follow-up time point.
Time frame
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.Sponsors and contacts
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Source ClinicalTrials.gov