rTMS for Depression

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?Major depressive disorder (MDD) is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing (e.g., the loss of pleasure) is one of the core features of MDD. Common treatments of MDD include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline), and psychological therapies and medication combined, but they may not address the function of the reward circuit in MDD. These treatments often do not improve depressive symptoms in MDD patients who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (dlPFC) for treatment of MDD. Many of these studies have shown that rTMS to the dlPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of MDD rather than in the dlPFC.

Eligibility Criteria

This trial is for adults aged 18-60 with Major Depressive Disorder, as indicated by specific depression scales. Participants must understand and consent to the study's procedures, not be pregnant or nursing if female, and have no metal implants that interfere with MRI or TMS.

Inclusion Criteria

Able to verbalize understanding of consent form, provide written informed consent, and verbalize willingness to complete study procedures

I am not pregnant or breastfeeding during the fMRI and TMS treatment periods.

I am between 18 and 60 years old.

+4 more

Exclusion Criteria

I cannot tolerate TMS treatment.

Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI at BCM

Contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.): Do not meet the pre-screening TMS safety questionnaire (TASS). Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation

+5 more

Participant Groups

The trial tests repetitive Transcranial Magnetic Stimulation (rTMS) on a brain area called the orbitofrontal cortex in people with depression who haven't fully responded to other treatments. It aims to see if rTMS can better alleviate depressive symptoms.

1Treatment groups

Experimental Treatment

Group I: rTMSExperimental Treatment1 Intervention

20 sessions of rTMS

Repetitive Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as rTMS for: