Deep Brain Stimulation for Psychosis

Conditions

• Treatment-Refractory Schizophrenia

Eligibility Criteria

Sex

ALL

Age

22 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Abbott Laboratories Infinity™ implantable deep brain stimulation system — DEVICE
  Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain

Study Details

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.

Key Dates

Start date

Apr 3, 2024

Status verified

Jun 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Randomized Discontinuation Period: OFF then ON DBS
  Subjects randomized to this arm are initially "OFF" DBS after the open label period then gradually decreased in their optimized setting's amplitude for 8 weeks and then "ON" DBS for 8 weeks.
• Experimental: Experimental: Randomized Discontinuation Period: ON then OFF DBS
  Subjects randomized to this arm are initially "ON" DBS with optimized stimulation settings for 8 weeks after the open label period and then "OFF" DBS with gradually decreasing amplitude for 8 weeks.

Primary Outcome Measure

Demonstrate device safety [ Time Frame: 3 years ]

Central Contacts

• Hila Abush Segev, Ph.D
  214-648-0401
  [email protected]

Locations (1)

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