Accelerated Neuromodulation of Prefrontal Circuitry During Clozapine Treatment
Overview
- Phase
- N/A
- Intervention
- sham stimulation
- Conditions
- Schizophrenia
- Sponsor
- Deepak K. Sarpal, M.D.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- change in activation of the working memory network
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
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.
Investigators
Deepak K. Sarpal, M.D.
Assistant Professor
University of Pittsburgh
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
Arms & Interventions
iTBS, then Sham
Intervention: sham stimulation
iTBS, then Sham
Intervention: transcranial magnetic stimulation
Sham, then iTBS
Intervention: sham stimulation
Sham, then iTBS
Intervention: transcranial magnetic stimulation
Outcomes
Primary Outcomes
change in activation of the working memory network
Time Frame: 1 hour
Examine whether accelerated intermittent theta burst stimulation (iTBS) is associated with functional magnetic resonance imaging (fMRI)-based changes in activation of the working memory network during AX-continuous performance task engagement
change in brain functional connectivity within the prefrontal cortex
Time Frame: 1 hour
Examine changes in left dorsolateral prefrontal cortex-basal forebrain functional connectivity following adjunctive accelerated intermittent theta burst stimulation (iTBS)
Secondary Outcomes
- explore change in functional magnetic resonance imaging (fMRI) measures versus plasma n-desmethylclozapine/clozapine ratios(1 month)