Psychosis TMS Study

Psychosis Clinical Trial

Official title:

Investigational TMS Study of Cognitive Impairment in Early Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857137
• Other study ID #: 2018P000014
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: Massachusetts General Hospital
• Contact: Alexandra O'Neill, B.S.
• Phone: (617) 726-8753
• Email: agoneill[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

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

Locations

Country	Name	City	State
United States	Martinos Center for Biomedical Imaging	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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