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Active, Not Recruiting

NCT Number: NCT05857137

Psychosis TMS Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Psychosis Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active TMS

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

Device

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

Primary outcomes

  1. Working memory accuracy

    Time frame: 2 hours

    Accuracy at high memory loads during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.

  2. Reaction time during working memory

    Time frame: 2 hours

    Reaction time during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.

  3. Resting state functional connectivity between the left inferior parietal lobule and the regions of the frontoparietal control network

    Time frame: 2 hours

    Functional connectivity between left inferior parietal lobule and dorsolateral prefrontal cortex will be computed during resting state acquired before and after the TMS interventions.

  4. Resting state functional connectivity within the default mode network

    Time frame: 2 hours

    Functional connectivity between left inferior parietal lobule and other regions of the default mode network (including the posterior cingulate cortex and the medial prefrontal cortex) will be computed during resting state acquired before and after the TMS interventions.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Investigational TMS Study of Cognitive Impairment in Early Psychosis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 12, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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