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NCT02361554 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation in Treatment Resistant Schizophrenia
A NA study of Treatment-resistant Schizophrenia, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT02361554: Recruiting NA study of Treatment-resistant Schizophrenia, sponsored by Johns Hopkins University.
NCT02361554 is a NA study of Treatment-resistant Schizophrenia that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02361554, a NA study of Treatment-resistant Schizophrenia, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this pilot study is to investigate the use of deep brain stimulation (DBS) of the substantia nigra pars reticulata (SNr) in subjects with treatment-resistant schizophrenia. There is a subset of patients with schizophrenia who continue to have persistent psychotic symptoms (auditory hallucinations and delusions) despite multiple adequate medication trials with antipsychotic medications including clozapine. There are currently no available treatments for such patients who generally have poor function and are chronically disabled, unable to work, live independently or have meaningful social relationships. Neuroimaging studies in patients with schizophrenia have revealed information about pathological neural circuits that could be suitable targets using deep brain stimulation. Although not yet tested in patients with schizophrenia, DBS is in early phase clinical trials in other psychiatric disorders. This pilot study will investigate the use of DBS in treatment-resistant schizophrenia subjects who have exhausted all other therapeutic alternatives but continue to have persistent disabling psychotic symptoms. Of note, DBS is not FDA approved for use in patients with schizophrenia. The method will be similar to that used in subthalamic nucleus stimulation in patients with Parkinson's Disease. However, the electrode will be advanced slightly inferior into the SNr, a major outflow nucleus of the basal ganglia, with the intention of causing local inhibition of SNr outflow resulting in disinhibition of the mediodorsal nucleus (MDN) of the thalamus. Hypofunction of the MDN has been implicated in the pathophysiology of schizophrenia in post-mortem as well as multiple structural and functional imaging studies. Evidence suggests that dysfunction of the MD is implicated in both positive and cognitive symptoms (such as working memory impairment) in schizophrenia. Frequent monitoring and clinical assessment with psychiatric scales will be used to monitor treatment res
Primary Outcome
We will assess deep brain stimulation effects on the positive and psychosis features of schizophrenia.
Conditions Studied
Interventions
- DEVICE Medtronic Percept with SensSight Deep Brain Stimulation System
Study Locations (1)
Maryland
- The Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2027-02 |
| Phase | NA |
What NCT02361554 shows while recruiting
NCT02361554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Treatment-resistant Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Medtronic Percept with SensSight Deep Brain Stimulation System is the first listed.
NCT02361554 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02361554 about?
NCT02361554 is a clinical study titled "Deep Brain Stimulation in Treatment Resistant Schizophrenia". The purpose of this pilot study is to investigate the use of deep brain stimulation (DBS) of the substantia nigra pars reticulata (SNr) in subjects with treatment-resistant schizophrenia. There is a subset of patients with schizophrenia who continue to have persistent psychotic symptoms (auditory ha...
What is the current status of trial NCT02361554?
This trial is currently recruiting. It is a NA study. The enrollment target is 6 participants. The study started on 2023-03-01. Estimated completion is 2027-02.
What conditions does trial NCT02361554 study?
This clinical trial studies the following conditions: Treatment-resistant Schizophrenia.
What interventions are being tested in trial NCT02361554?
The interventions under investigation include: Medtronic Percept with SensSight Deep Brain Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT02361554?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02361554 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02361554's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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