Deep Brain Stimulation for Psychosis

This study is exploring the use of Deep Brain Stimulation (DBS) with the Abbott Laboratories Infinity™ implantable system for individuals aged 22 to 70 who have treatment-resistant schizophrenia. DBS involves delivering a small electrical current to a specific area of the brain. The researchers want to see if this device is safe over three years and if it can help change brain activity to a non-psychotic state. They also aim to understand if specific stimulation settings can lead to these changes. This study is currently recruiting a small group of 10 participants.

Study design
This is an interventional study with a planned enrollment of 10 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for device safety for at least 3 years.

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NCT06257056

Deep Brain Stimulation for Psychosis

Recruiting
NAAges 22–70InterventionalTreatment
Bradley Lega
~10 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Abbott Laboratories Infinity™ implantable deep brain stimulation system

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrate device safety
Measured over 3 years
Treatment-Refractory Schizophrenia
1 sites across 1 states
Texas1
  • Bradley Lega, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
  • David McDonagh, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
  • Nader Pouratian, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
  • Carol Tamminga, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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  • Demonstrate device safety3 years

    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.