Psychosis TMS Study

Study Overview
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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.

Official Title
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Investigational TMS Study of Cognitive Impairment in Early Psychosis

Conditions
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Psychosis

Intervention / Treatment
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* Device: Active TMS
* Device: Placebo TMS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive impairment, Transcranial Magnetic Stimulation, Attention, Short-term memory