Brief Summary

This will be a single site pilot study. 30 subjects with Early Phase Psychosis (EPP), defined as medical record documentation of the onset of clinically significant psychotic symptoms within the past ten years, will be enrolled. Prior to randomization (Session 1), subjects will undergo Functional Magnetic Resonance Imaging (fMRI) during Episodic Memory (EM) and Resting State (RS) paradigms. This baseline scan will also include a high-resolution structural sequence for neuronavigation purposes. Then on three separate days each occurring one-week apart, subjects will receive one session of inhibitory (1 Hertz \[Hz\]) Repetitive Transcranial Magnetic Stimulation (rTMS), one session of excitatory (20 Hz) rTMS, and one sham stimulation session targeting the precuneus. The order of the three interventions will be randomized. Immediately following each rTMS or sham session, subjects will undergo repeat fMRI during EM and RS paradigms. The investigators will also examine the effect of rTMS on EM performance.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline

Completed

Started Nov 2019

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

October 28, 2019

Completed

11 days until next milestone

Study Start

First participant enrolled

November 8, 2019

Completed

24 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 28, 2023

Completed

Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

2.6 years

First QC Date

October 28, 2019

Results QC Date

May 2, 2023

Last Update Submit

July 10, 2023

Conditions

Schizophrenia

Keywords

schizophreniapsychosisearly phase psychosisrTMS

Outcome Measures

Primary Outcomes (3)

Change in Precuneus Functional Activation
Change in estimated beta coefficients for the Target vs. Foil contrast during scene recognition in the precuneus. Beta coefficients reflect the strength of the blood oxygen-level dependent (BOLD) signal during each condition.Target images are those previously shown to participants, and Foil images have not been previously shown, as participants indicate whether they have been shown images. A higher measure indicates that the intervention increased brain activity during recognition of previously shown scenes.
1 day
Precuneus Functional Connectivity
Blood oxygen level dependent (BOLD) signal functional connectivity with the precuneus in the bilateral dorsolateral prefrontal cortex, hippocampus, and anterior cingulate cortex. Value is the mean Fisher's transform of the correlation of BOLD time-series in the precuneus with the BOLD time-series in other named regions. Higher values indicate greater connectivity with the precuneus following the intervention. Value of zero indicates no relationship (no connectivity). This value has no unit of measurement.
1 day
Performance During In-scanner Episodic Memory Task
Percent accuracy (0-100%) on detecting whether an image shown during a scene recognition was among those shown during the previous five-minute session. Higher scores indicate better performance in recalling images.
1 day

Study Arms (6)

1 Hz rTMS Stimulation first, then 20 Hz rTMS Stimulation, then sham rTMS

EXPERIMENTAL

Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.