Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6 participants
INTERVENTIONAL
2022-11-01
2025-12-31
Brief Summary
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* whether patients with treatment-resistant schizophrenia can benefit from hippocampus-targeted DBS;
* what is the neural and electrophysiological mechanism underlying the treatment effect of hippocampus-targeted DBS.
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Detailed Description
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The next phase will consist of the crossover study. Patients who respond to DBS will be randomly assigned to two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months.
Participants will receive PET-CT, clinical assessment and cognitive tests at the main study points to evaluate treatment efficacy and patient tolerance, and to reveal the underlying mechanism of the treatment effect of DBS.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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On-Stimulation
Disease condition is assessed with stimulation turned "on".
On-Stimulation
The surgical electrode implanted in hippocampus by a pulse generating device is "on".
Off-Stimulation
Disease condition is assessed with stimulation turned "off".
Off-Stimulation
The surgical electrode implanted in hippocampus by a pulse generating device is "off".
Interventions
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On-Stimulation
The surgical electrode implanted in hippocampus by a pulse generating device is "on".
Off-Stimulation
The surgical electrode implanted in hippocampus by a pulse generating device is "off".
Eligibility Criteria
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Inclusion Criteria
* Having a diagnosis of schizophrenia according to DSM-IV criteria
* Having a chronic, recurrent course of disease with a five-year minimum duration
* Determined to be treatment-resistant as demonstrated by:
1. Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.
2. Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.
3. Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.
4. Presence of persistent positive symptom defined as i) requiring a score of 4 (moderate) or more on at least 2 of the next PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items.
* Maintaining stable pharmacological treatment for two months preceding screening visit.
* Informed consent
Exclusion Criteria
* Severe physical illness
* Contraindications to neurosurgery, MRI or PET-CT;
* Substance abuse or dependence
* Mental retardation
* Female patients who are pregnant or breastfeeding
* Severe suicide risk and tendencies
18 Years
55 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Shanghai Mental Health Center
OTHER
Responsible Party
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Dengtang LIU
Chief Psychiatrist and Professor
Principal Investigators
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Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Lu C, Zhai Z, Zhuo K, Xiang Q, Xue J, Zhao Y, Lang L, Shao C, Chen L, Liu D. Deep brain stimulation of Hippocampus in Treatment-resistant Schizophrenia (DBS-HITS): protocol for a crossover randomized controlled trial. BMC Psychiatry. 2024 Nov 25;24(1):847. doi: 10.1186/s12888-024-06318-6.
Other Identifiers
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82171496
Identifier Type: -
Identifier Source: org_study_id
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