SchizophreniaREDOCSNCT05102929
Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia
A study testing active intermittent Theta Burst Stimulation (iTBS) in people with Schizophrenia, run by Fabio Ferrarelli at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- active intermittent Theta Burst Stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Fabio Ferrarelli, 4128641668, ferrarellif@upmc.edu
About this study
Official title: Enhancing Prefrontal Oscillatory Activity and Working Memory Performance With Noninvasive Brain Stimulation in Early-course Schizophrenia
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.
Read the detailed description
The overarching goal of this proposal is to establish whether, by acutely enhancing dorsolateral prefrontal cortex (DLPFC) oscillatory deficits experimentally, there is a corresponding improvement in working memory (WM) function in early-course schizophrenia (EC-SCZ) patients. To achieve this goal, the investigators will perform TMS/EEG assessments of DLPFC and related oscillatory parameters and evaluate WM ability with the AX-Continuous Performance Task (AX-CPT) before and after two theta burst stimulation (TBS) sessions (intermittent (iTBS) and sham TBS of DLPFC) in 75 EC-SCZ patients.
Aim 1. Establish the acute effects of active vs. sham TBS on DLPFC oscillatory activity/NF of EC-SCZ patients. The investigators will iTBS to enhance DLPFC oscillatory activity/NF, as assessed with TMS/EEG, in EC-SCZ patients.
H1: TBS condition (active vs sham) will moderate the change in DLPFC oscillatory activity/NF from pre to post-TBS, such that DLPFC oscillatory activity/NF will increase following iTBS (but not sham).
Aim 2. Assess the impact of acute active vs. sham TBS on WM performance in EC-SCZ patients. The investigators will assess the acute impact of active vs. sham iTBS on WM performance in EC-SCZ patients.
H2: iTBS condition (active vs sham) will moderate the change in WM from pre- to post-TBS, such that AX-CPT performance will improve following iTBS (but not sham).
Aim 3. Examine the relationship between TBS-related changes in DLPFC oscillatory activity/NF and WM performance in EC-SCZ patients.
H3: iTBS-induced increase in DLPFC oscillatory activity/NF will predict better post-iTBS WM performance in EC-SCZ patients.
- Conditions
- Schizophrenia
- Being tested
- active intermittent Theta Burst Stimulation (iTBS), sham intermittent Theta Burst Stimulation (iTBS)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active intermittent Theta Burst Stimulation (iTBS)Device
Also called Transcranial Magnetic Stimulation
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.
sham intermittent Theta Burst Stimulation (iTBS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFC | Experimental | This arm will first receive active iTBS stimulation and then sham iTBS over the left dorsolateral prefrontal cortex (DLPFC). Receives: Device: active intermittent Theta Burst Stimulation (iTBS); Device: sham intermittent Theta Burst Stimulation (iTBS) |
| sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFC | Experimental | This arm will first receive sham iTBS (i.e., with the TMS coil in the placebo orientation) and then active iTBS stimulation over the left dorsolateral prefrontal cortex (DLPFC). Receives: Device: active intermittent Theta Burst Stimulation (iTBS); Device: sham intermittent Theta Burst Stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dorsolateral prefrontal cortex natural frequency (DLPFC NF) following iTBS
The difference in prefrontal natural frequency (DLPFC NF) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Measured: baseline (pre iTBS), within one hour from iTBS
Change in dorsolateral prefrontal event-related spectral perturbation (DLPFC ERSP) following iTBS
The difference in prefrontal event-related spectral perturbation (DLPFC ERSP) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Measured: baseline (pre iTBS), within one hour from iTBS
Change in dorsolateral prefrontal inter-trial coherence (DLPFC ITC) following iTBS
The difference in prefrontal inter trial coherence (DLPFC ITC) between pre- and post- intermittent Theta Burst Stimulation (iTBS) in EC-SCZ patients
Measured: baseline (pre iTBS), within one hour from iTBS
Change in AX-Continuous Performance Task Reaction Time (AX-CPT RT) following 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
Measured: baseline (pre iTBS), within one hour from iTBS
Change in AX-Continuous Performance Task Error Rate (AX-CPT ER) following 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
Measured: baseline (pre iTBS), within one hour from iTBS
Change in AX-Continuous Performance Task d' context (AX-CPT d') following 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
Measured: baseline (pre iTBS), within one hour from iTBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start5 Nov 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fabio Ferrarelli
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Fabio Ferrarelli, University of Pittsburgh
- Investigators
- Fabio Ferrarelli, MD, PhD, Principal investigator, University of Pittsbrugh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102929
- Sponsor's protocol ID
- STUDY20050194
- Other IDs
- 1R01MH125816-01A1
- Acronym
- REDOCS
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Prefrontal Oscillatory Activity and Working Memory Performance With Noninvasive Brain Stimulation in Early-course Schizophrenia
- ClinicalTrials.gov ID
- NCT05102929
- Acronym / sponsor ID
- REDOCS / STUDY20050194
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Fabio FerrarelliUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overarching goal of this proposal is to establish whether, by acutely enhancing dorsolateral prefrontal cortex (DLPFC) oscillatory deficits experimentally, there is a corresponding improvement in working memory (WM) function in early-course schizophrenia (EC-SCZ) patients. To achieve this goal, the investigators will perform TMS/EEG assessments of DLPFC and related oscillatory parameters and evaluate WM ability with the AX-Continuous Performance Task (AX-CPT) before and after two theta burst stimulation (TBS) sessions (intermittent (iTBS) and sham TBS of DLPFC) in 75 EC-SCZ patients.
Aim 1. Establish the acute effects of active vs. sham TBS on DLPFC oscillatory activity/NF of EC-SCZ patients. The investigators will iTBS to enhance DLPFC oscillatory activity/NF, as assessed with TMS/EEG, in EC-SCZ patients.
H1: TBS condition (active vs sham) will moderate the change in DLPFC oscillatory activity/NF from pre to post-TBS, such that DLPFC oscillatory activity/NF will increase following iTBS (but not sham).
Aim 2. Assess the impact of acute active vs. sham TBS on WM performance in EC-SCZ patients. The investigators will assess the acute impact of active vs. sham iTBS on WM performance in EC-SCZ patients.
H2: iTBS condition (active vs sham) will moderate the change in WM from pre- to post-TBS, such that AX-CPT performance will improve following iTBS (but not sham).
Aim 3. Examine the relationship between TBS-related changes in DLPFC oscillatory activity/NF and WM performance in EC-SCZ patients.
H3: iTBS-induced increase in DLPFC oscillatory activity/NF will predict better post-iTBS WM performance in EC-SCZ patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFC | Experimental | Device: active intermittent Theta Burst Stimulation (iTBS), Device: sham intermittent Theta Burst Stimulation (iTBS)This arm will first receive active iTBS stimulation and then sham iTBS over the left dorsolateral prefrontal cortex (DLPFC). |
| sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFC | Experimental | Device: active intermittent Theta Burst Stimulation (iTBS), Device: sham intermittent Theta Burst Stimulation (iTBS)This arm will first receive sham iTBS (i.e., with the TMS coil in the placebo orientation) and then active iTBS stimulation over the left dorsolateral prefrontal cortex (DLPFC). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active intermittent Theta Burst Stimulation (iTBS)Also: Transcranial Magnetic StimulationiTBS 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 | active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFC, sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFC |
| 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. | Device | active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFC, sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFC |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Ferrarelli, MD, PhD principal investigator
University of Pittsbrugh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active intermittent Theta Burst Stimulation (iTBS) in people with Schizophrenia, run by Fabio Ferrarelli at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Janssen (412-246-6114, janssensa@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dorsolateral prefrontal cortex natural frequency (DLPFC NF) following iTBS (time frame: baseline (pre iTBS), within one hour from iTBS). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.