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Deep Brain Stimulation for Psychosis

NCT06257056 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-30

No results posted yet for this 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

  • Treatment-Refractory Schizophrenia

Interventions

DEVICE

Abbott 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

Sponsors & Collaborators

  • Bradley Lega

    lead OTHER

Principal Investigators

  • Bradley Lega, M.D. · UT Southwestern Medical Center

  • David McDonagh, M.D. · UT Southwestern Medical Center

  • Nader Pouratian, M.D. · UT Southwestern Medical Center

  • Carol Tamminga, M.D. · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257056 on ClinicalTrials.gov