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Hippocampus DBS in Treatment-resistant Schizophrenia

NCT05694000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-01-23

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the efficacy and safety of hippocampus-targeted deep brain stimulation (DBS) in treatment-resistant schizophrenia. The main question it aims to answer are:

* 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.

Conditions

  • Treatment-resistant Schizophrenia

Interventions

DEVICE

On-Stimulation

The surgical electrode implanted in hippocampus by a pulse generating device is "on".

DEVICE

Off-Stimulation

The surgical electrode implanted in hippocampus by a pulse generating device is "off".

Sponsors & Collaborators

  • Huashan Hospital

    collaborator OTHER

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05694000 on ClinicalTrials.gov