Using TMS to Treat Rumination in Patients with 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
This study is testing if Transcranial Magnetic Stimulation (TMS) can help adults with treatment-resistant depression by reducing their negative thoughts and improving their mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06511544 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Transcranial Magnetic Stimulation (TMS) on the ventromedial prefrontal cortex (VMPFC) in adults suffering from treatment-resistant depression. The study aims to determine whether TMS can alter brain activity during negative self-referential tasks and reduce rumination, a common symptom in depression. Participants will undergo a series of functional MRI scans and TMS treatments, with assessments conducted before, during, and after the intervention to evaluate changes in brain function and depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with unipolar major depressive disorder who have not responded to at least one antidepressant medication.
Not a fit: Patients with psychotic features or those who have not experienced a prior depressive episode before age 50 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with depression who have not responded to traditional medications.
How similar studies have performed: Previous studies have shown promising results using TMS for depression, suggesting potential for success in this novel application targeting rumination.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Goodman Hall Neuroscience Center — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Susan K Conroy, MD PhD — Indiana University
- Study coordinator: Susan K Conroy, MD PhD
- Email: sconroy@iu.edu
- Phone: 317-963-7300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.