rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Repetitive Transcranial Magnetic Stimulation of the Ventromedial Prefrontal Cortex to Target Neural Connectivity and Rumination in Treatment-Resistant Major Depressive Disorder: A Pilot Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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?"
- "Participants will: Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task"
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether TMS, which uses magnetic pulses to stimulate the brain, can reduce rumination—getting stuck on negative thoughts. It is for adults with major depression that has not improved with at least one antidepressant. Participants will have 20 TMS treatments, three MRI brain scans, questionnaires, and a computer task.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have major depression confirmed by the study doctors, without psychosis, such as seeing or hearing things that are not there.
- Had your first period of depression before age 50.
- Have moderate to severe depression now, with a depression rating score of at least 17.
- Have tried at least one antidepressant for your current depression at a high enough dose and for long enough, without improvement.
- Take no mental health medicines, or have taken the same doses for at least 6 weeks and agree to keep those doses during the study.
- Can understand the study and agree to take part.
- Can safely have an MRI scan.
Who can't join
- Are at immediate risk of suicide, or your current period of depression has lasted more than 5 years.
- Have another significant mental health condition, significant problems with thinking or memory, or a significant substance use disorder within the past 6 months.
- Started talk therapy or a treatment such as light therapy within 6 weeks of screening, or joined a trial of an experimental drug or device during that time.
- Have ever had TMS, did not improve with ECT (a treatment that uses electricity to cause a controlled seizure), or had surgery to treat a brain, nerve, or mental health condition.
- Have an unstable medical illness or a significant brain or nerve condition, such as a serious head injury, stroke, or Parkinson’s disease. A movement condition called benign essential tremor is allowed.
- Have epilepsy, a history of seizures, or a condition or medicine that raises seizure risk. Some childhood fever-related seizures or seizures with a known trigger may be allowed.
- Are pregnant or plan to become pregnant during the study, or have an implanted electronic device, such as a pacemaker or hearing implant.
- Cannot see the words shown inside the MRI scanner without glasses.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 Exclusion Criteria: * 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
Study sites (1)
IN
- Goodman Hall Neuroscience Center · Indianapolis, IN 46202Susan K Conroy, MD PhD · Study contact · 317-963-7300 · sconroy@iu.eduMore trials in Indianapolis