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Recruiting NCT06562153

fMRI Accelerated TMS Depression

— Observational Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuroimaging with Magnetic Resonance Imaging (MRI).
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Tracking Brain Imaging Changes in Depression Over Clinical Accelerated Transcranial Magnetic Stimulation (TMS) Therapy at the Individual Level

Overview

This study aims to investigate whether phenotypic-related brain states revealed by a novel INSCAPE ("Individualized Network-based Single-frame Coactivation Pattern Estimation") neuroimaging method in Major Depressive Disorder (MDD) patients can track brain recovery of MDD patients over an accelerated antidepressant transcranial magnetic stimulation (TMS) treatment.

Detailed description

The aim of this study is to use magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to assess brain states. This study will recruit participants who are scheduled to receive accelerated Transcranial Magnetic Stimulation (TMS) therapy for Major Depressive Disorder (MDD). Participation in this study involves two visits, each including a 30-minute MRI scan. The interval between each visit is about one week. Depressed participants will also complete mood assessments at various intervals while they are receiving accelerated TMS for depression.

Interventions

  • Other Neuroimaging with Magnetic Resonance Imaging (MRI)
    MRI will be used to observe brain states over time.

Primary outcome measures

  • Dynamic brain state change after 5-day transcranial magnetic stimulation (TMS) treatment compared to baseline [Time frame: 5 days]

Eligibility criteria

Inclusion criteria

  • Age 18-65
  • Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
  • DSM-IV diagnosis of MDD

Exclusion criteria

  • Unable to speak English.
  • Contraindicated for MRI.
  • Any current or recent untreated medical, neurological, or psychiatric conditions
  • Metal implant devices in the head, heart, or neck.
  • History of brain surgery.
  • History of cortisol medication use or electroconvulsive therapy.
  • Comorbidity with other psychiatric/neurological illnesses or personality disorders
  • History of myocardial infarction or arrhythmia, bradycardia.
  • Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
  • Individuals suffering from frequent/severe headaches.
  • Moderate to severe alcohol or substance use disorder.
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • 30 Bee Street — Charleston

Identifiers

NCT: NCT06562153 · Pro00138260

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗