Recruiting

Prefrontal Oscillations

Sponsor:

Fabio Ferrarelli

Code:

NCT05102929

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

active intermittent Theta Burst Stimulation (iTBS)

sham intermittent Theta Burst Stimulation (iTBS)

Study Details

Brief 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.

Conditions

Schizophrenia

Study ID

NCT05102929

Start date

Nov 5, 2021

Status verified date

Aug, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ages 18-40 years
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:

1. DSM intellectual developmental disorder
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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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).

experimental: 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).

Interventions

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.

Primary outcome measure

  • Change in dorsolateral prefrontal cortex natural frequency (DLPFC NF) following iTBS [ Time Frame: baseline (pre iTBS), within one hour from iTBS ]
  • Change in dorsolateral prefrontal event-related spectral perturbation (DLPFC ERSP) following iTBS [ Time Frame: baseline (pre iTBS), within one hour from iTBS ]
  • Change in dorsolateral prefrontal inter-trial coherence (DLPFC ITC) following iTBS [ Time Frame: baseline (pre iTBS), within one hour from iTBS ]
  • Change in AX-Continuous Performance Task Reaction Time (AX-CPT RT) following iTBS [ Time Frame: baseline (pre iTBS), within one hour from iTBS ]
  • Change in AX-Continuous Performance Task Error Rate (AX-CPT ER) following iTBS [ Time Frame: baseline (pre iTBS), within one hour from iTBS ]
  • Change in AX-Continuous Performance Task d' context (AX-CPT d') following iTBS [ Time Frame: baseline (pre iTBS), within one hour from iTBS ]

Central Contacts and Locations

Central contacts

Sabine Janssen

412-246-6114janssensa@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Fabio Ferrarelli

4128641668ferrarellif@upmc.edu

More Information

Sponsor

Fabio Ferrarelli

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fabio Ferrarelli on 2026-08-11.