Actively Recruiting
Deep Brain Stimulation for Psychosis
Led by Bradley Lega · Updated on 2025-05-30
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Deep Brain Stimulation for Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women (non-pregnant) between ages 22 and 70
- Diagnosis of schizophrenia as the primary diagnosis confirmed by structured clinical interview
- Medically healthy without any serious acute medical disorders
- Treatment refractory with non-sustained response to at least two different antipsychotic drugs from two chemical families and to either electroconvulsive therapy or clozapine trial
- Experiencing active and ongoing psychotic symptoms that are continuous and aversive
- PANSS score of 90 or higher on two assessments over one month
- At least one PANSS positive subscale item scored 5 or greater
- Normal brain MRI within 3 months before surgery
- Stable antipsychotic medication regimen for one month before surgery
- Normal thyroid stimulating hormone level within 12 months before study entry
- Other medical conditions stable for at least 6 months
- Able and willing to give informed consent and attend regular clinic visits for at least 12 months after surgery
- Able to have a treating psychiatrist or close relative present for consent discussions
- Willing to sign a treatment contract
- Preference given to participants with family or caregiver support
- For women of childbearing potential: negative pregnancy blood test during screening and study, use of highly effective birth control, participation only after confirmed menstrual period
- For men: use of highly effective birth control during study participation
You will not qualify if you...
- Active alcohol or substance use disorder within 6 months, excluding nicotine; positive urine drug test for illicit drugs
- Current substantial suicidal risk or suicide attempt within last year
- Neurological or medical conditions that make surgery unsafe
- History of seizure disorder, hemorrhagic stroke, or high seizure risk
- Medical contraindications to surgery such as infection
- Bleeding disorders or abnormal blood clotting tests
- Uncontrolled hypertension despite treatment
- Heart-rate corrected QT interval greater than 450 msec
- Participation in another drug, device, or biological study within 90 days
- Current implanted stimulation devices like pacemakers or neurostimulators
- Need for diathermy
- Chronic use of anticoagulant or anti-platelet agents that cannot be stopped safely for surgery
- Psychiatric, neurological, or medical conditions making participant a poor candidate
- Female participants of childbearing potential unwilling or unable to use birth control or provide negative pregnancy tests
- Cardiac conditions posing unacceptable risk for anesthesia or ketamine
- Poorly controlled hypertension or persistent tachycardia at baseline
- Use of antidepressant medication
- Contraindications to ketamine or esketamine including hypersensitivity, aneurysmal vascular disease, intracerebral hemorrhage, abnormal resting heart rate, or medication interactions
- History of benzodiazepine or CNS depressant use requiring special monitoring during ketamine phase
- Positive urine drug screen for contraindicated substances on ketamine administration day
- Other medical or psychiatric conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
H
Hila Abush Segev, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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