TMS for Psychosis

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Summary

This trial uses noninvasive TMS & MRI to study brain activity in people with early psychosis, to understand how memory works.

Who is the study for?

This trial is for individuals within the first ten years of experiencing psychotic symptoms, diagnosed with conditions like schizophrenia, schizoaffective disorder, or bipolar with psychosis. Participants must be able to understand and agree to the study's procedures.

What is being tested?

The study is testing how working memory functions in early psychosis patients using Transcranial Magnetic Stimulation (TMS) alongside brain imaging. TMS uses magnetic fields on the scalp to influence brain activity noninvasively.

What are the potential side effects?

TMS may cause discomfort at the site of application, headaches, lightheadedness, or seizures in rare cases. It's generally considered safe but can have different effects depending on individual sensitivity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reaction time during working memory

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

Resting state functional connectivity within the default mode network

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TMSExperimental Treatment1 Intervention

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

Group II: Placebo TMSPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active TMS

2017

Completed Phase 2

~160

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