AzTrials
AzTrials

Schizophrenia DisordersNCT07671261

SEEG-Guided DBS for Schizophrenia

A study testing SEEG implantation and Deep brain stimulation in people with Schizophrenia Disorders and Schizo Affective Disorder, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
SEEG implantation and Deep brain stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteChina
Study dates
17 Aug 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shuo Ma, PhD contact

86+15000838003

ms13144@rjh.com.cn

China1 site, 1 recruiting

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Shuo Ma, PhD, 86+15000838003, ms13144@rjh.com.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.

Being tested
SEEG implantation, Deep brain stimulation
Keywords
Schizophrenia, Stereoelectroencephalography, Neuroimaging, deep brain stimulation
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEEG implantationProcedure or surgery

    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.

  • Deep brain stimulationDevice

    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.

Study groups in NCT07671261
Study groupRoleWhat they receive
Stim ON-OFFActive comparatorParticipants 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.
Receives: Procedure: SEEG implantation; Device: Deep brain stimulation
Stim OFF-ONPlacebo comparatorParticipants 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.
Receives: Procedure: SEEG implantation; Device: Deep brain stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.

  5. Improvement Rate of Cognitive Function (Assessed by MoCA)

    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.

    Measured: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2026
  2. Study start17 Aug 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07671261
Sponsor's protocol ID
SEEG-Guided DBS for TRS
Status last verified
Jul 2025
First submitted
22 Jun 2026
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vilela-Filho O, Ragazzo PC, Canedo D, Barreto US, Oliveira PM, Goulart LC, Reis MD, Campos TM. The impact of subcaudate tractotomy on delusions and hallucinations in psychotic patients. Surg Neurol Int. 2021 Sep 20;12:475. doi: 10.25259/SNI_599_2021. eCollection 2021.

    PubMed 34621590

  • Vaernet K, Madsen A. Stereotaxic amygdalotomy and basofrontal tractotomy in psychotics with aggressive behaviour. J Neurol Neurosurg Psychiatry. 1970 Dec;33(6):858-63. doi: 10.1136/jnnp.33.6.858.

    PubMed 5531905

  • Liu W, Hao Q, Zhan S, Li D, Pan S, Li Y, Lin G, Pan G, Mahyoub R, Sun B. Long-term follow-up of mri-guided bilateral anterior capsulotomy in patients with refractory schizophrenia. Stereotact Funct Neurosurg. 2014;92(3):145-52. doi: 10.1159/000360861. Epub 2014 May 7.

    PubMed 24818571

  • Scangos KW, Khambhati AN, Daly PM, Makhoul GS, Sugrue LP, Zamanian H, Liu TX, Rao VR, Sellers KK, Dawes HE, Starr PA, Krystal AD, Chang EF. Closed-loop neuromodulation in an individual with treatment-resistant depression. Nat Med. 2021 Oct;27(10):1696-1700. doi: 10.1038/s41591-021-01480-w. Epub 2021 Oct 4.

    PubMed 34608328

  • Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C, Schwalb JM, Kennedy SH. Deep brain stimulation for treatment-resistant depression. Neuron. 2005 Mar 3;45(5):651-60. doi: 10.1016/j.neuron.2005.02.014.

    PubMed 15748841

  • Sun FT, Morrell MJ, Wharen RE Jr. Responsive cortical stimulation for the treatment of epilepsy. Neurotherapeutics. 2008 Jan;5(1):68-74. doi: 10.1016/j.nurt.2007.10.069.

    PubMed 18164485

  • Motamedi GK, Lesser RP, Miglioretti DL, Mizuno-Matsumoto Y, Gordon B, Webber WR, Jackson DC, Sepkuty JP, Crone NE. Optimizing parameters for terminating cortical afterdischarges with pulse stimulation. Epilepsia. 2002 Aug;43(8):836-46. doi: 10.1046/j.1528-1157.2002.24901.x.

    PubMed 12181002

  • Lesser RP, Kim SH, Beyderman L, Miglioretti DL, Webber WR, Bare M, Cysyk B, Krauss G, Gordon B. Brief bursts of pulse stimulation terminate afterdischarges caused by cortical stimulation. Neurology. 1999 Dec 10;53(9):2073-81. doi: 10.1212/wnl.53.9.2073.

    PubMed 10599784

  • Limousin P, Krack P, Pollak P, Benazzouz A, Ardouin C, Hoffmann D, Benabid AL. Electrical stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 1998 Oct 15;339(16):1105-11. doi: 10.1056/NEJM199810153391603.

    PubMed 9770557

  • Benabid AL, Pollak P, Gervason C, Hoffmann D, Gao DM, Hommel M, Perret JE, de Rougemont J. Long-term suppression of tremor by chronic stimulation of the ventral intermediate thalamic nucleus. Lancet. 1991 Feb 16;337(8738):403-6. doi: 10.1016/0140-6736(91)91175-t.

    PubMed 1671433

  • Milosevic L, Kalia SK, Hodaie M, Lozano AM, Fasano A, Popovic MR, Hutchison WD. Neuronal inhibition and synaptic plasticity of basal ganglia neurons in Parkinson's disease. Brain. 2018 Jan 1;141(1):177-190. doi: 10.1093/brain/awx296.

    PubMed 29236966

  • Lozano AM, Lipsman N. Probing and regulating dysfunctional circuits using deep brain stimulation. Neuron. 2013 Feb 6;77(3):406-24. doi: 10.1016/j.neuron.2013.01.020.

    PubMed 23395370

  • Hoang KB, Turner DA. The Emerging Role of Biomarkers in Adaptive Modulation of Clinical Brain Stimulation. Neurosurgery. 2019 Sep 1;85(3):E430-E439. doi: 10.1093/neuros/nyz096.

    PubMed 30957145

  • Dostrovsky JO, Lozano AM. Mechanisms of deep brain stimulation. Mov Disord. 2002;17 Suppl 3:S63-8. doi: 10.1002/mds.10143.

    PubMed 11948756

  • Daalman K, Diederen KM, Hoekema L, van Lutterveld R, Sommer IE. Five year follow-up of non-psychotic adults with frequent auditory verbal hallucinations: are they still healthy? Psychol Med. 2016 Jul;46(9):1897-907. doi: 10.1017/S0033291716000386. Epub 2016 Mar 10.

    PubMed 26961499

Questions about this trial

What is this clinical trial studying?

A study testing SEEG implantation and Deep brain stimulation in people with Schizophrenia Disorders and Schizo Affective Disorder, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shuo Ma, PhD (86+15000838003, ms13144@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction Rate of PANSS Positive Subscale or SAPS (time frame: Baseline (pre-operation), 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks post-operation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07671261, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
SEEG-Guided DBS for Schizophrenia (NCT07671261) | AzTrials