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NCT07592611 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
A NA study, sponsored by Johns Hopkins University.
- Not yet
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT07592611: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT07592611 is a NA study that has not yet begun recruiting, run by Johns Hopkins University. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07592611, a NA study, has not yet begun recruiting, sponsored by Johns Hopkins University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
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
Investigators will assess deep brain stimulation effects on the positive and psychosis features of schizophrenia. Total scores range from 18 to 126. A higher score indicates a more severe psychiatric symptom rating.
Interventions
- DEVICE Medtronic Percept with SensSight Deep Brain Stimulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2029-06-28 |
| Phase | NA |
What is known before NCT07592611 opens enrollment
NCT07592611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Medtronic Percept with SensSight Deep Brain Stimulation System is the first listed.
NCT07592611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07592611 about?
NCT07592611 is a clinical study titled "Deep Brain Stimulation for 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 NCT07592611?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2026-08-01. Estimated completion is 2029-06-28.
What interventions are being tested in trial NCT07592611?
The interventions under investigation include: Medtronic Percept with SensSight Deep Brain Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT07592611?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07592611's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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