Personalized brain stimulation treatment for depression
Engaging the Subgenual Cingulate With Brain Stimulation for Depression
This study is testing a personalized brain stimulation treatment for depression to see if it can help people feel better over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06266390 on ClinicalTrials.gov |
What this trial studies
This study investigates how the subgenual anterior cingulate cortex (sgACC) responds during transcranial magnetic stimulation (TMS) in individuals with depression. Participants will undergo a series of assessments, including questionnaires and MRI scans, to identify personalized TMS targets. The treatment phase consists of daily TMS sessions over six weeks, with additional MRI scans to monitor brain engagement. Follow-up assessments will evaluate the long-term effects of the treatment on depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of major or persistent depressive disorder.
Not a fit: Patients with current psychosis, mania, or those who have previously failed TMS or ECT treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatments for individuals suffering from depression.
How similar studies have performed: Other studies have shown promise in using TMS for depression, but this specific individualized approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. 18-65 years old 2. Diagnosis of major depressive or persistent depressive disorder as per SCID clinical interview. 3. Patient Health Questionnaire-9 (PHQ-9) score = or \> than 10 4. Comprehension of instructions in the English language. 5. Capacity to provide informed consent and follow study procedures. 6. Availability for the duration of the study. Exclusion Criteria 1. Current psychosis, mania, or substance use disorder 2. Prior failed response to full repetitive Transcranial Magnetic Stimulation (rTMS) treatment or Electroconvulsive Therapy/Magnetic Seizure Therapy (ECT/MST) trial. 3. While SSRI (Selective Serotonin Reuptake Inhibitors) and SNRI (Serotonin-Norepinephrine Reuptake Inhibitors) medications are permitted, specific guidelines apply: * Patients taking lithium, antipsychotics, TCAIs, MAOIs, or atypical antidepressants will be excluded. * Participants taking benzodiazepines must abstain from taking them 24 hours before visits. * Patients taking Bupropion (Wellbutrin) above 350 mg will be excluded. 4. History of neurological disorder or traumatic brain injury (other than mild). 5. Unable to have an MRI scan, or current or prior medical condition that could interfere with the collection or interpretation of MRI data 6. Unable to receive or tolerate TMS 7. Implanted devices, such as an aneurysm clip or cardiac pacemaker 8. History of stroke, epilepsy, or brain scarring 9. Pregnant, nursing, or trying to become pregnant (self-attestation alone) 10. Acute sleep deprivation or medication/substance intoxication or withdrawal (TMS seizure risk) 11. Current use of stimulants, cyclosporine, tacrolimus (or others that can cause leukoencephalopathy). Stimulants for ADHD/ADD will be considered on a case-by-case basis per PI discretion. 12. Dialysis 13. Transportation limits or physical limits to attending daily M-F treatment sessions 14. Per study physician discretion medications likely to interfere with blood flow or otherwise compromise functional imaging measures In addition, during this study participants will be asked to: 1. Refrain from substance use (including marijuana and illicit drugs) for the duration of the study 2. Abstain from alcohol for 24 hours before the MRI scans 3. Abstain from increasing caffeine intake or beginning any new medications
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Camilla Whitesel
- Email: camilla.whitesel@pennmedicine.upenn.edu
- Phone: 215-573-0828
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.