Psychosis TMS Study

Not Applicable

Active, not recruiting

• Conditions: Psychosis
• Interventions: Device: Placebo TMS; Device: Active TMS

• Registration Number: NCT05857137
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-04
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Status Verified: 2024-11
• Primary Completion: 2024-11-20
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reaction time during working memory	2 hours	Reaction time during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.
Resting state functional connectivity between the left inferior parietal lobule and the regions of the frontoparietal control network	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.
Working memory accuracy	2 hours	Accuracy at high memory loads during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.
Resting state functional connectivity within the default mode network	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.

Trial Locations

Locations (1)

Martinos Center for Biomedical Imaging; 🇺🇸 Charlestown, Massachusetts, United States