Psychosis TMS Study

Investigational TMS Study of Cognitive Impairment in Early Psychosis

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.

Study Overview

• Status: Recruiting
• Conditions: Psychosis
• Intervention / Treatment: Device: Active TMS; Device: Placebo TMS

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra O'Neill, B.S.; Phone Number: (617) 726-8753; Email: agoneill@mgh.harvard.edu
• Study Contact Backup: Name: Hamdi Eryilmaz, Ph.D; Phone Number: (617) 643-7462; Email: hamdi.eryilmaz@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Martinos Center for Biomedical Imaging
      • Contact: Alexandra O'Neill, B.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TMS; Participants will receive single-session administration of TMS. Functional MRI will be acquired before and immediately after the intervention.	Device: 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.
Placebo Comparator: 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.	Device: Placebo TMS; Placebo TMS will be applied over the left inferior parietal lobule for approximately 3 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working memory accuracy	Accuracy at high memory loads during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.	2 hours
Reaction time during working memory	Reaction time during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.	2 hours
Resting state functional connectivity between the left inferior parietal lobule and the regions of the frontoparietal control network	Functional connectivity between left inferior parietal lobule and dorsolateral prefrontal cortex will be computed during resting state acquired before and after the TMS interventions.	2 hours
Resting state functional connectivity within the default mode network	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.	2 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Attention; Transcranial Magnetic Stimulation; Cognitive impairment; Short-term memory
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 2018P000014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No