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SEEG-Guided DBS for Schizophrenia

22 giugno 2026 aggiornato da: Bomin Sun, Ruijin Hospital

Deep Brain Stimulation for Treatment-Refractory Schizophrenia: Individualized Target Selection and Efficacy

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This clinical trial aims to systematically evaluate the efficacy and safety of SEEG-guided target screening combined with individualized deep brain stimulation (DBS) for treatment-refractory schizophrenia.

The study first employs Stereoelectroencephalography (SEEG) electrodes as the core tool to establish a personalized, minimally invasive neuromodulation surgical framework. After SEEG electrode implantation, researchers will collect and analyze high-spatiotemporal-resolution electrophysiological data during both resting-state and task-state conditions, as well as identify characteristic electrophysiological biomarkers that correlate with clinical symptoms.

Secondly, electrical stimulation is delivered through the SEEG contacts to functionally verify candidate targets in different brain regions. By stimulating specific targets and observing immediate symptomatic or physiological responses, we validate the effects on neural circuits and confirm their functional relevance prior to any permanent intervention. For targets that show preliminary efficacy, we further apply externalized chronic stimulation to continuously monitor symptom improvement and potential adverse effects.

After determine the optimal targets and the intervention is confirmed to be both effective and safe, we implant a permanent brain pacemaker (DBS device). During the efficacy follow-up phase, we employ a randomized crossover design, which is then followed by an open-label period. These two stages enable thorough assessment of clinical efficacy. Meanwhile, we also collect multidimensional data (clinical symptoms, cognition, and neuroimaging) to explore the circuit mechanisms of stimulation.

Tipo di studio

Interventistico

Iscrizione (Stimato)

46

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200025
        • Reclutamento
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Stim ON-OFF

Participants randomized to the Stim ON-OFF arm will first undergo bilateral stereoelectroencephalography (SEEG) electrode implantation targeting brain regions associated with schizophrenia symptoms, followed by stimulation response assessments.

Secondly, deep brain stimulation will be performed based on the electrophysiological recordings and stimulation assessment results.

Thirdly, participants will receive active stimulation during the randomization phase for up to 12 weeks. The participants will then have their device turned off and receive sham stimulation during the crossover phase for up to 12 weeks.
Procedura: SEEG implantation
Phase 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.
Dispositivo: Deep brain stimulation
Phase 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.
Comparatore placebo: Stim OFF-ON

Participants randomized to the Stim OFF-ON arm will first undergo bilateral stereoelectroencephalography (SEEG) electrode implantation targeting brain regions associated with schizophrenia symptoms, followed by stimulation response assessments.

Secondly, deep brain stimulation will be performed based on the electrophysiological recordings and stimulation assessment results.

Thirdly, participants will have their device turned off and receive sham stimulation during the randomization phase for up to 12 weeks. The participants will then receive active stimulation during the crossover phase for up to 12 weeks.
Procedura: SEEG implantation
Phase 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.
Dispositivo: Deep brain stimulation
Phase 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction Rate of PANSS Positive Subscale or SAPS
Lasso di tempo: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
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.
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction Rate of Auditory Hallucinations (Assessed by PSYRATS-AH)
Lasso di tempo: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
The severity of auditory hallucinations is assessed using the Psychotic Symptom Rating Scales - Auditory Hallucinations subscale (PSYRATS-AH). Higher scores indicate greater symptom severity.
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
Reduction Rate of Delusions (Assessed by PSYRATS-D)
Lasso di tempo: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
The severity of delusions is assessed using the Psychotic Symptom Rating Scales - Delusions subscale (PSYRATS-D). Higher scores indicate greater symptom severity.
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
Reduction Rate of Depressive Symptoms (Assessed by HAMD)
Lasso di tempo: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
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.
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
Reduction Rate of Anxiety Symptoms (Assessed by HAMA)
Lasso di tempo: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
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.
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
Improvement Rate of Cognitive Function (Assessed by MoCA)
Lasso di tempo: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.
General cognitive performance is assessed using the Montreal Cognitive Assessment (MoCA). The MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function. Unlike symptom rating scales, the outcome here focuses on the positive percentage change (improvement rate) or absolute point increase in the MoCA total score from baseline to each follow-up time point.
Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ruijin Hospital

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 agosto 2025

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 giugno 2026

Ultimo verificato

1 luglio 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SEEG-Guided DBS for TRS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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