Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia
NCT ID: NCT05102929
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2021-11-05
2026-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFC
This arm will first receive active iTBS stimulation and then sham iTBS over the left dorsolateral prefrontal cortex (DLPFC).
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.
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.
sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFC
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).
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. DSM diagnoses of Schizophrenia Spectrum Axis I disorders
3. 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
2. significant head injury
3. medical illness affecting brain structure or function
4. significant neurologic disorder (e.g. seizure disorder)
5. personal history or family history of epilepsy
6. inability to provide informed consent
7. concussion with loss of consciousness (LOC) greater than 10 minutes
8. history of electroconvulsive therapy
9. diabetes with associated seizures, loss of sensation/weakness in arms or legs, or momentary LOC
10. pregnancy or postpartum (\<6 weeks after delivery or miscarriage), as determined by self-report
11. a psychotic illness with a temporal relation to substance use or head injury.
12. current or past co-morbidity for alcohol or psychoactive substance dependence
13. substance abuse, other than cannabis and/or alcohol, within the past one year
18 Years
40 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Fabio Ferrarelli
OTHER
Responsible Party
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Fabio Ferrarelli
Associate Professor
Principal Investigators
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Fabio Ferrarelli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsbrugh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20050194
Identifier Type: -
Identifier Source: org_study_id
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