Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Fabio Ferrarelli
Study ID
NCT05102929
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • active intermittent Theta Burst Stimulation (iTBS) — DEVICE
    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 Details

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.

Key Dates

Start date
Nov 5, 2021
Status verified
Jun 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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).

Primary Outcome Measure

Change in dorsolateral prefrontal cortex natural frequency (DLPFC NF) following iTBS [ Time Frame: baseline (pre iTBS), within one hour from iTBS ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Fabio Ferrarelli
[email protected]
4128641668

Find similar trials in Pittsburgh, PA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Pittsburgh· Pittsburgh, PA

Related Studies