Transcranial Magnetic Stimulation for Depression (FREED Trial)

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare 3 types of TBS (Theta Burst Stimulation) in 75 people with TRD (treatment-resistant depression). EEG data will be collected to measure changes in fronto-parietal theta connectivity and depressive symptoms. Hypothesis: Ind-iTBS will be more effective than targeted-iTBS and standard iTBS.

Who is the study for?

This trial is for adults aged 18-80 with major depressive disorder who haven't improved after trying at least one antidepressant. They must be able to consent, have a moderate to severe depression score, and not have started new antidepressants recently.

What is being tested?

The FREED study tests three types of Transcranial Magnetic Stimulation (TMS) treatments over four weeks: fully individualized iTBS targeting frequency and E-field, iTBS targeting only E-field, and standard iTBS. It measures changes in brain connectivity and depression severity.

What are the potential side effects?

Common side effects of TMS may include discomfort at the treatment site, headache, lightheadedness, or seizures in rare cases. Individual experiences with side effects can vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from pre-treatment in fronto-parietal theta connectivity at post-treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: iTBS individualized using E-field targeting only (targeted-iTBS)Active Control1 Intervention

In the targeted-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting.

Group II: The fully individualized form of iTBS (BOTH the frequency and E-field targeting approaches)Active Control1 Intervention

In the Ind-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting. The stimulation frequency will also be individualized according to EEG-derived TGC.

Group III: Standard iTBS treatment (i.e., typical iTBS localized to the DLPFC using the Beam F3 method)Active Control1 Intervention

The standard iTBS will be delivered with the typical 5Hz/50Hz patterned frequencies used in the FDA-approved treatment protocol and stimulation will be delivered according to the Beam F3 targeting.

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