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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 is a NA study of Treatment-Refractory Schizophrenia that is actively recruiting participants, run by Bradley Lega. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06257056
The ClinicalTrials.gov registry entry for NCT06257056 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bradley Lega, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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