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NCT06257056 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation for Psychosis
A NA study of Treatment-Refractory Schizophrenia, sponsored by Bradley Lega.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06257056: Recruiting NA study of Treatment-Refractory Schizophrenia, sponsored by Bradley Lega.
NCT06257056 is a NA study of Treatment-Refractory Schizophrenia that is actively recruiting participants, run by Bradley Lega. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06257056, a NA study of Treatment-Refractory Schizophrenia, is actively recruiting participants, sponsored by Bradley Lega.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
There are three hypotheses proposed for this study: 1) Participants will report no unanticipated serious adverse events during the eight months of treatment. 2) Investigators will successfully model psychotic versus non-psychotic brain states using support vector machine (SVM) classifiers. 3) Participants specific brain stimulation parameters can induce a change in the brain state consistent with non-psychotic states as measured by classifier output. Hypotheses 1, 2, and 3 address safety and tolerability, efficacy, and the putative mechanism of successful treatment. The overall objective is to use next generation Deep Brain Stimulation (DBS) combined with antecedent stereo electroencephalogram (SEEG) mapping to establish a new therapy for treatment-refractory schizophrenia given the limitations of current treatment modalities. The primary objective is to demonstrate safety of acute and chronic network guided stimulation for treatment-refractory schizophrenia. Exploratory Objectives: 1. Use intracranial mapping (SEEG) combined with pharmacological manipulation of psychotic states to create a protocol for participant specific deep brain stimulation to treat treatment-refractory schizophrenia. 2. Develop closed loop stimulation protocols to modify brain states during psychotic brain activity induced by low-dose ketamine administration. 3. Investigate the use of mnemonic similarity to characterize brain networks related to symptoms of treatment-refractory schizophrenia. 4. Treatment-related objectives: Record a reduction in psychotic symptoms, as well as an improvement in psychosocial function and cognition.
Primary Outcome
The primary objective is to demonstrate safety of acute and chronic network guided stimulation for treatment-refractory schizophrenia. This is determined if participants with the Deep Brain Stimulation Device demonstrate no significant device related serious adverse events (SAE). Device safety will be measured by number of reported SAE's in year 2 and 3.
Conditions Studied
Interventions
- DEVICE Abbott Laboratories Infinity™ implantable deep brain stimulation system
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2027-04 |
| Phase | NA |
What NCT06257056 shows while recruiting
NCT06257056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 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 1 condition, with Treatment-Refractory Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Abbott Laboratories Infinity™ implantable deep brain stimulation system is the first listed.
NCT06257056 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06257056 about?
NCT06257056 is a clinical study titled "Deep Brain Stimulation for Psychosis". There are three hypotheses proposed for this study: 1) Participants will report no unanticipated serious adverse events during the eight months of treatment. 2) Investigators will successfully model psychotic versus non-psychotic brain states using support vector machine (SVM) classifiers. 3) Partic...
What is the current status of trial NCT06257056?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2024-04-03. Estimated completion is 2027-04.
What conditions does trial NCT06257056 study?
This clinical trial studies the following conditions: Treatment-Refractory Schizophrenia.
What interventions are being tested in trial NCT06257056?
The interventions under investigation include: Abbott Laboratories Infinity™ implantable deep brain stimulation system (DEVICE).
Who is sponsoring clinical trial NCT06257056?
This trial is sponsored by Bradley Lega, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06257056 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06257056's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 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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