RECRUITING

rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression

Conditions

Depression, Treatment Resistant transcranial magnetic stimulation functional magnetic resonance imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if Transcranial Magnetic Stimulation (TMS) to part of the brain called the ventromedial prefrontal cortex (VMPFC) can treat a symptom called rumination in adults with major depression that has not responded to at least one medication trial. The main question it aims to answer are: Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging (fMRI) during a negative self-referential processing task in adults with depression? Does TMS to the VMPFC affect rumination in adults with depression? Researchers will compare brain scans and rumination scores before, during, and immediately after TMS. Participants will: Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task

Official Title

Repetitive Transcranial Magnetic Stimulation of the Ventromedial Prefrontal Cortex to Target Neural Connectivity and Rumination in Treatment-Resistant Major Depressive Disorder: A Pilot Study

Quick Facts

Study Start:2024-01-02

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06511544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of unipolar major depressive disorder without psychotic features by the Mini-International Neuropsychiatric Interview (MINI) and confirmed by study psychiatrist * First depressive episode prior to age 50 * Current moderate to severe depression, Hamilton Depression Rating Scale (HDRS) ≥17) * Failure to respond to ≥1 antidepressant medication at adequate dose and duration in the current depressive episode; (note: this criterion is designed to be consistent with the original 2008 FDA-labeled indication for TMS in Major Depressive Disorder, that specifies failure to respond to "one prior medication at or above the minimal effective dose and duration in the current episode" (https://www.accessdata.fda.gov/cdrh_docs/pdf8/K083538.pdf). )) * Off psychotropic medications OR on a stable dose of medication(s) for 6 weeks, and willing to remain on stable medication dosage throughout the study * Capacity to consent * Ability to safely receive MRI	* Actively/imminently suicidal, Quick Inventory of Depressive Symptomatology (QIDS) item 12 score \>2) * Current depressive episode duration \> 5 years * Presence of clinically significant psychiatric diagnoses other than unipolar, non-psychotic major depression, such as post-traumatic stress disorder (PTSD) or obsessive-compulsive disorder (OCD) * Evidence of cognitive impairment, Montreal Cognitive Assessment (MOCA) \< 23) * Significant substance use disorder within past 6 months * New-onset psychotherapy and/or somatic therapy (e.g., light therapy) within 6 weeks of screening * Prior exposure to any form of TMS * Have participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening * Failure to respond to Electroconvulsive therapy (ECT) * Any history of neurosurgery to treat a neurologic or psychiatric disorder (e.g. Vagus nerve stimulation, cortical stimulation, deep brain stimulation, or ablative surgery) * Unstable medical illness * Evidence or history of significant neurological disorder, including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor) * Epilepsy * History of seizures (except juvenile febrile seizures or provoked seizures at the PI's discretion) or any condition/concurrent medication that could notably lower seizure threshold * Pregnancy or planned pregnancy during the study * Presence of cardiac pacemaker, cochlear implant, or other implanted electronic device * Any vision problem that will prevent them from seeing the adjectives presented inside the MRI scanner without glasses

Inclusion Criteria

Exclusion Criteria

* Diagnosis of unipolar major depressive disorder without psychotic features by the Mini-International Neuropsychiatric Interview (MINI) and confirmed by study psychiatrist
* First depressive episode prior to age 50
* Current moderate to severe depression, Hamilton Depression Rating Scale (HDRS) ≥17)
* Failure to respond to ≥1 antidepressant medication at adequate dose and duration in the current depressive episode; (note: this criterion is designed to be consistent with the original 2008 FDA-labeled indication for TMS in Major Depressive Disorder, that specifies failure to respond to "one prior medication at or above the minimal effective dose and duration in the current episode" (https://www.accessdata.fda.gov/cdrh_docs/pdf8/K083538.pdf). ))
* Off psychotropic medications OR on a stable dose of medication(s) for 6 weeks, and willing to remain on stable medication dosage throughout the study
* Capacity to consent
* Ability to safely receive MRI

* Actively/imminently suicidal, Quick Inventory of Depressive Symptomatology (QIDS) item 12 score \>2)
* Current depressive episode duration \> 5 years
* Presence of clinically significant psychiatric diagnoses other than unipolar, non-psychotic major depression, such as post-traumatic stress disorder (PTSD) or obsessive-compulsive disorder (OCD)
* Evidence of cognitive impairment, Montreal Cognitive Assessment (MOCA) \< 23)
* Significant substance use disorder within past 6 months
* New-onset psychotherapy and/or somatic therapy (e.g., light therapy) within 6 weeks of screening
* Prior exposure to any form of TMS
* Have participated in any clinical trial with an investigational drug or device within the past 6 weeks prior to screening
* Failure to respond to Electroconvulsive therapy (ECT)
* Any history of neurosurgery to treat a neurologic or psychiatric disorder (e.g. Vagus nerve stimulation, cortical stimulation, deep brain stimulation, or ablative surgery)
* Unstable medical illness
* Evidence or history of significant neurological disorder, including moderate-severe head trauma, stroke, Parkinson's disease or other movement disorder (except benign essential tremor)
* Epilepsy
* History of seizures (except juvenile febrile seizures or provoked seizures at the PI's discretion) or any condition/concurrent medication that could notably lower seizure threshold
* Pregnancy or planned pregnancy during the study
* Presence of cardiac pacemaker, cochlear implant, or other implanted electronic device
* Any vision problem that will prevent them from seeing the adjectives presented inside the MRI scanner without glasses

Contacts and Locations

Study Contact

Susan K Conroy, MD PhD

CONTACT

317-963-7300

sconroy@iu.edu

Principal Investigator

Susan K Conroy, MD PhD

PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Study Locations (Sites)

Goodman Hall Neuroscience Center

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana University

Susan K Conroy, MD PhD, PRINCIPAL_INVESTIGATOR, Indiana University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-01-02

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

transcranial magnetic stimulation
functional magnetic resonance imaging

Additional Relevant MeSH Terms

Depression, Treatment Resistant