NCT05857137

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2023Jul 2026

Study Start

First participant enrolled

April 4, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

May 4, 2023

Last Update Submit

February 6, 2026

Conditions

Psychosis

Keywords

Cognitive impairmentTranscranial Magnetic StimulationAttentionShort-term memory

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Active TMS

EXPERIMENTAL

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

Device: Active TMS

Placebo TMS

PLACEBO COMPARATOR

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

Interventions

Active TMSDEVICE

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.

Active TMS
Placebo TMSDEVICE

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

Placebo TMS

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Psychotic DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 12, 2023

Study Start

April 4, 2023

Primary Completion

April 15, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)