Psychosis TMS Study

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2026-07-30

Brief Summary

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The main goal of this study is to investigate the neural mechanisms of working memory function in patients with early psychosis using Transcranial Magnetic Stimulation (TMS) in conjunction with functional MRI. TMS is a noninvasive method used to modulate brain activity via changing magnetic fields applied over the surface of the scalp.

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Detailed Description

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Conditions

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Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active TMS

Participants will receive single-session administration of TMS. Functional MRI will be acquired before and immediately after the intervention.

Group Type EXPERIMENTAL

Active TMS

Intervention Type DEVICE

Continuous theta burst stimulation (cTBS) will be administered over the left inferior parietal lobule for approximately 3 minutes at 120% of the resting motor threshold.

Placebo TMS

Participants will also receive single session administration of placebo TMS (at least two days apart from the day of the active TMS). Functional MRI will be acquired before and immediately after the intervention.

Group Type PLACEBO_COMPARATOR

Placebo TMS

Intervention Type DEVICE

Placebo TMS will be applied over the left inferior parietal lobule for approximately 3 minutes.

Interventions

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Active TMS

Continuous theta burst stimulation (cTBS) will be administered over the left inferior parietal lobule for approximately 3 minutes at 120% of the resting motor threshold.

Intervention Type DEVICE

Placebo TMS

Placebo TMS will be applied over the left inferior parietal lobule for approximately 3 minutes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of psychosis, psychosis not otherwise specified, schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder with psychosis, and schizophreniform disorder within first ten years of onset of psychotic symptoms.
* Ability to provide informed consent

Exclusion Criteria

* TMS incompatibility including metallic implants in head and neck, cardiac pacemakers, history of seizures, pregnancy.
* MRI-incompatibility including implanted aneurism clips, cardiac pacemakers, metal implants, intrauterine devices, tattoos containing metal ink, pregnancy, and claustrophobia
* Severe substance abuse within 3 months (nicotine allowed)
* Unstable medical or neurologic illness that would preclude participation in study procedures

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No