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Clinical Trial

Deep Brain Stimulation for Psychosis

NCT: NCT06257056 · RECRUITING

NCT IDNCT06257056
StatusRECRUITING
Start Date2024-04-03
Completion2027-04
SponsorBradley Lega (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Deep Brain Stimulation for Psychosis?

Deep Brain Stimulation for Psychosis is a clinical trial registered under NCT06257056. Current status: RECRUITING.

What is the status of NCT06257056?

The current status of NCT06257056 (Deep Brain Stimulation for Psychosis) is: RECRUITING.

When did Deep Brain Stimulation for Psychosis start?

Deep Brain Stimulation for Psychosis started on 2024-04-03.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.