NCT05102929 · Fabio Ferrarelli
Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia
(REDOCS)
What this study is about
This study will investigate the effects of intermittent Theta Burst Stimulation (iTBS) on natural oscillatory frequency of the dorsolateral prefrontal cortex (DLPFC) and working memory in early-course schizophrenia (EC-SCZ). Transcranial magnetic stimulation (TMS) will be used to evoke oscillatory activity, and EEG will record the responses of EC-SCZ participants.
View original scientific description
This study will investigate the effects of intermittent Theta Burst Stimulation (iTBS) on natural oscillatory frequency of the dorsolateral prefrontal cortex (DLPFC) and working memory in early-course schizophrenia (EC-SCZ). Transcranial magnetic stimulation (TMS) will be used to evoke oscillatory activity, and EEG will record the responses of EC-SCZ participants. A working memory task will also be incorporated in order to determine how DLPFC natural frequency (NF) is related to working memory performance. iTBS (active or sham) will be administered, then the oscillatory activity of DLPFC and working memory performance will be reassessed. The overarching goal is to determine whether iTBS can acutely enhance the oscillatory activity of the DLPFC and to evaluate the relationship between changes in the DLPFC and working memory performance.
Interventions
DEVICE
active intermittent Theta Burst Stimulation (iTBS)
iTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with patients with schizophrenia. This research study is using iTBS off label in SCZ patients to examine research questions.
DEVICE
sham intermittent Theta Burst Stimulation (iTBS)
Sham TBS over the left DLPFC will be performed using a Cool-B65 A/P TMS coil, designed to support blinded clinical trials. Specifically, when the coil is placed in the "P" position (i.e. the "placebo" position), only a very small amount of current is induced in tissue, thus preventing the activation of cortical neurons.
Primary outcome measures
Change in dorsolateral prefrontal cortex natural frequency (DLPFC NF) following iTBS
Time frame: baseline (pre iTBS), within one hour from iTBS
The difference in prefrontal natural frequency (DLPFC NF) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Change in dorsolateral prefrontal event-related spectral perturbation (DLPFC ERSP) following iTBS
Time frame: baseline (pre iTBS), within one hour from iTBS
The difference in prefrontal event-related spectral perturbation (DLPFC ERSP) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Change in dorsolateral prefrontal inter-trial coherence (DLPFC ITC) following iTBS
Time frame: baseline (pre iTBS), within one hour from iTBS
The difference in prefrontal inter trial coherence (DLPFC ITC) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Change in AX-Continuous Performance Task Reaction Time (AX-CPT RT) following iTBS
Time frame: baseline (pre iTBS), within one hour from iTBS
The difference in AX-Continuous Performance Task Reaction Time (AX-CPT RT) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Change in AX-Continuous Performance Task Error Rate (AX-CPT ER) following iTBS
Time frame: baseline (pre iTBS), within one hour from iTBS
The difference in AX-Continuous Performance Task Error Rate (AX-CPT ER) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Change in AX-Continuous Performance Task d' context (AX-CPT d') following iTBS
Time frame: baseline (pre iTBS), within one hour from iTBS
The difference in AX-Continuous Performance Task d' context (AX-CPT d') between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ages 18-40 years
- DSM diagnoses of Schizophrenia Spectrum Axis I disorders
- a duration of less than three years from beginning of psychosis, defined by report of symptoms and/or history of treatment, based on clinical guidelines employed in our UPMC psychoses clinics in Pittsburgh.
Exclusion criteria
- DSM intellectual developmental disorder
- significant head injury
- medical illness affecting brain structure or function
- significant neurologic disorder (e.g. seizure disorder)
- personal history or family history of epilepsy
- inability to provide informed consent
- concussion with loss of consciousness (LOC) greater than 10 minutes
- history of electroconvulsive therapy
- diabetes with associated seizures, loss of sensation/weakness in arms or legs, or momentary LOC
- pregnancy or postpartum (\<6 weeks after delivery or miscarriage), as determined by self-report
- a psychotic illness with a temporal relation to substance use or head injury.
- current or past co-morbidity for alcohol or psychoactive substance dependence
- substance abuse, other than cannabis and/or alcohol, within the past one year
Where
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2026 · Source of record for eligibility and locations