Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia (NCT05102929) | Clinical Trial Compass
RecruitingNot Applicable
Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia
United States75 participantsStarted 2021-11-05
Plain-language summary
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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in dorsolateral prefrontal cortex natural frequency (DLPFC NF) following iTBS
Timeframe: baseline (pre iTBS), within one hour from iTBS
2
Change in dorsolateral prefrontal event-related spectral perturbation (DLPFC ERSP) following iTBS
Timeframe: baseline (pre iTBS), within one hour from iTBS
3
Change in dorsolateral prefrontal inter-trial coherence (DLPFC ITC) following iTBS
Timeframe: baseline (pre iTBS), within one hour from iTBS
4
Change in AX-Continuous Performance Task Reaction Time (AX-CPT RT) following iTBS
Timeframe: baseline (pre iTBS), within one hour from iTBS
5
Change in AX-Continuous Performance Task Error Rate (AX-CPT ER) following iTBS
Timeframe: baseline (pre iTBS), within one hour from iTBS
6
Change in AX-Continuous Performance Task d' context (AX-CPT d') following iTBS
Timeframe: baseline (pre iTBS), within one hour from iTBS