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Psychosis TMS Study

Primary Purpose

Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active TMS
Placebo TMS
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychosis focused on measuring Cognitive impairment, Transcranial Magnetic Stimulation, Attention, Short-term memory

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Martinos Center for Biomedical ImagingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active TMS

Placebo TMS

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Reaction time during working memory
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05857137
Brief Title
Psychosis TMS Study
Official Title
Investigational TMS Study of Cognitive Impairment in Early Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Cognitive impairment, Transcranial Magnetic Stimulation, Attention, Short-term memory

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TMS
Arm Type
Experimental
Arm Description
Participants will receive single-session administration of TMS. Functional MRI will be acquired before and immediately after the intervention.
Arm Title
Placebo TMS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active TMS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo TMS
Intervention Description
Placebo TMS will be applied over the left inferior parietal lobule for approximately 3 minutes.
Primary Outcome Measure Information:
Title
Working memory accuracy
Description
Accuracy at high memory loads during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.
Time Frame
2 hours
Title
Reaction time during working memory
Description
Reaction time during performance of the Sternberg Item Recognition Paradigm will be assessed before and after the TMS interventions.
Time Frame
2 hours
Title
Resting state functional connectivity between the left inferior parietal lobule and the regions of the frontoparietal control network
Description
Functional connectivity between left inferior parietal lobule and dorsolateral prefrontal cortex will be computed during resting state acquired before and after the TMS interventions.
Time Frame
2 hours
Title
Resting state functional connectivity within the default mode network
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra O'Neill, B.S.
Phone
(617) 726-8753
Email
agoneill@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hamdi Eryilmaz, Ph.D
Phone
(617) 643-7462
Email
hamdi.eryilmaz@mgh.harvard.edu
Facility Information:
Facility Name
Martinos Center for Biomedical Imaging
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra O'Neill, B.S.

12. IPD Sharing Statement

Plan to Share IPD
No

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Psychosis TMS Study

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