Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

SEEG-Guided DBS for Schizophrenia

22 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

46

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Werving
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Procedure: 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.
Apparaat: 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.
Placebo-vergelijker: 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.
Procedure: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reduction Rate of PANSS Positive Subscale or SAPS
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reduction Rate of Auditory Hallucinations (Assessed by PSYRATS-AH)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ruijin Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 augustus 2025

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 juli 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SEEG-Guided DBS for TRS

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren