Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sham stimulation, transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Schizoaffective Disorder. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment
Overview
In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.
Interventions
- Device sham stimulation
sham delivery of transcranial magnetic stimulation - Device transcranial magnetic stimulation
accelerated intermittent theta burst stimulation
Primary outcome measures
- change in brain functional connectivity within the prefrontal cortex [Time frame: 1 hour]
- change in activation of the working memory network [Time frame: 1 hour]
Secondary outcome measures (1)
- explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- A current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-defined diagnosis of schizophrenia or schizoaffective disorder
- age 18-50 years
- at least 4 months of clozapine treatment
- history of at least 2 failed antipsychotic trials
- competency and willingness to sign informed consent
- A clinically optimized dosage of clozapine, unchanged for at least 1 month, with a minimum of 150 mg/day
Exclusion criteria
- Serious neurologic or medical condition/treatment that impacts the brain
- a significant risk of suicidal or homicidal behavior
- cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
- pregnancy or postpartum (<6 weeks after delivery or miscarriage)
- history of treatment with electroconvulsive therapy
- contraindications for magnetic resonance imaging (e.g., a pacemaker)
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)-verified moderate or severe substance use disorder, including alcohol use disorder
- seizure disorder or prior history of seizures on clozapine
- patients taking both bupropion and clozapine
- prior issues with intermittent theta burst stimulation/transcranial magnetic stimulation administration
Concomitant treatment with serotonin and norepinephrine reuptake inhibitors will be examined on a case-by-case basis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- UPMC Western Psychiatric Hospital/University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT06003036 · STUDY23050056 · R21MH134128