Psychosis TMS Study

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05857137

Collaborator

(none)

Enrollment

Location

Arms

24.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychosis	Device: Active TMS Device: Placebo TMS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Investigational TMS Study of Cognitive Impairment in Early Psychosis

Actual Study Start Date :

Apr 4, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Martinos Center for Biomedical Imaging	Charlestown	Massachusetts	United States	02129

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hamdi Eryilmaz, PhD, Assistant Professor, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05857137

Other Study ID Numbers:

2018P000014

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Hamdi Eryilmaz, PhD, Assistant Professor, Massachusetts General Hospital

Cognitive impairment

Transcranial Magnetic Stimulation

Attention

Short-term memory

Additional relevant MeSH terms:

Psychotic Disorders

Mental Disorders

Study Results

No Results Posted as of May 12, 2023