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NCT06266390Completed

Individualized (fMRI-guided) TMS Treatment for Depression

Engaging the Subgenual Cingulate With Brain Stimulation for Depression

Source: ClinicalTrials.gov · Last updated 23 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to investigate the responses of the brain region known as the subgenual anterior cingulate cortex (sgACC) during transcranial magnetic stimulation (TMS) in individuals with depression. Specifically, investigators aim to determine whether the sgACC is engaged when TMS is delivered to specific targets and if the engagement of sgACC changes throughout a full TMS treatment intervention. To achieve this goal, the investigators will employ a combination of TMS and Magnetic Resonance Imaging (MRI) procedures. Study participation will include completing various questionnaires, clinical assessments, receiving a full transcranial magnetic stimulation (TMS) treatment intervention (every weekday for 6 weeks), and undergoing MRI scans, both with and without concurrent TMS.

Status (registry)
Completed
Study type
Interventional
Enrollment
54 (actual)
First submitted
8 Jan 2024
Start date
29 May 2024
Primary completion date
14 Apr 2026
Lead sponsor
University of Pennsylvania
Diseases
Depression
NCT number
NCT06266390

What you commit to

  • Study type: Interventional
  • Participants enrolled: 54
  • From 29 May 2024 to the primary completion date, 14 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Implanted medical devices, metallic implants, or drug infusion pumps that are not MRI-safe (e.g., aneurysm clips, defibrillators, or cochlear implants)
  • Prior failed response to full rTMS or ECT/MST trial. Any successful prior treatments are acceptable and support a prognosis that a new rTMS treatment would be worth attempting.
  • Per study physician discretion medications likely to interfere with blood flow or otherwise compromise functional imaging measures.
  • Refrain from substance use (including marijuana and illicit drugs) for the duration of the study
  • Inform the study team of any new medical treatments or prescribed medications (e.g., antibiotics) to allow for safety review and determination of continued eligibility for the study.

Other illness

  • History of significant medical events (e.g., stroke, seizures, brain scarring) or neurological/neurodevelopmental conditions (e.g., epilepsy) that are contraindications for TMS and MRI or may adversely affect brain function and data interpretation.
  • Current psychosis, mania, or substance use disorder
  • Acute systemic infection, high fever
  • Acute sleep deprivation or medication/substance intoxication or withdrawal (TMS seizure risk)
  • Current use of Bupropion (Wellbutrin) above 300 mg, benzodiazepines, lithium, monoamine oxidase inhibitors (MAOIs), and/or high doses of stimulant medication is exclusionary. Note: Exclusionary dosages or medications may be reduced or discontinued under the supervision of a medical provider. Participants must provide documentation confirming that their medical provider has agreed to oversee any medication changes, as abrupt changes can lower the seizure threshold and are contraindicated for TMS.
  • Not initiate, discontinue, or adjust any psychiatric medications or therapy treatments during the study period.

Other

  • Inability to complete an MRI scan (e.g., claustrophobia, inability to remain still for extended periods).
  • Inability to tolerate TMS administration
  • Significant handicaps that would interfere with testing procedures
  • Current use of cyclosporine, tacrolimus, or others that can cause leukoencephalopathy.
  • Pregnancy
  • Dialysis
  • Suicide attempt in past 6 months (safety precaution)
  • Transportation limits or physical limits to attending daily M-F treatment sessions.
  • Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from procedure site; unlikely to be able to schedule daily treatment sessions, etc.)
    • In addition, during this study participants will be asked to:
  • Abstain from alcohol for 24 hours before study visits.
  • Maintain a consistent level of caffeine consumption throughout the study period and avoid any significant increases.

Who the study is looking for

  • 18-65 years old
  • DSM-5 diagnosis of major depressive (at least 90%) or persistent depressive disorder (no more than 10%) as per SCID clinical interview.
  • Patient Health Questionnaire-9 (PHQ-9) score = or \> than 10
  • Comprehension of instructions in the English language.
  • Capacity to provide informed consent and follow study procedures.
  • Availability for the duration of the study.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.