RecruitingNot ApplicableNCT06257056

Deep Brain Stimulation for Psychosis

Closed Loop Neuromodulation for Treatment-refractory Schizophrenia: A Pilot Study


Sponsor

Bradley Lega

Enrollment

10 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing deep brain stimulation (DBS) — a surgical procedure that uses electrical impulses to certain brain areas — as a possible treatment for severe, treatment-resistant schizophrenia. This is for people whose psychotic symptoms have not improved with multiple medications. **You may be eligible if...** - You are between 22 and 70 years old - You have a confirmed diagnosis of schizophrenia as your primary condition - You have tried at least two different antipsychotic medications without lasting benefit - You have also tried either electroconvulsive therapy (ECT) or clozapine without lasting benefit - Your psychotic symptoms remain severe and constant (PANSS score ≥90) - Your brain MRI is normal and your antipsychotic medication has been stable for at least one month before surgery - You have a caregiver or family member who can support you through the study **You may NOT be eligible if...** - You are pregnant or planning to become pregnant - You have another active serious medical condition - You do not have someone to help support your participation - You are unable or unwilling to attend clinic visits for at least 12 months after surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAbbott Laboratories Infinity™ implantable deep brain stimulation system

Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT06257056