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Brain Stimulation

rTMS for Depression (R01RF Trial)

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

All subjects must be between 18-75 years of age

Must have confirmed diagnosis of severe Major Depressive Disorder as confirmed by the Mini-International Neuropsychiatric Interview (MINI) or a score of 17 or above on the Hamilton Depression Rating Scale (HAMD)

Must not have

Diagnosis of acute or chronic psychotic symptoms or disorders in the current depressive episode

Are mentally or legally incapacitated, unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week per subject (three rf measurements will happen within 1 week)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to develop a personalized brain stimulation treatment for major depressive disorder using repetitive transcranial magnetic stimulation (rTMS). Researchers will compare different rTMS frequencies targeting a specific brain region in

Who is the study for?

This trial is for individuals with Major Depressive Disorder (MDD) who are interested in a novel brain stimulation treatment. Participants will need to commit to multiple sessions and assessments over 4 weeks, including MRI scans and EEGs.

What is being tested?

The study tests personalized repetitive transcranial magnetic stimulation (rTMS) frequencies targeting the left dorsolateral prefrontal cortex. It compares three different rTMS frequencies: one that maximizes brain circuit engagement, one that's least engaging, and a standard frequency of 10 Hz.

What are the potential side effects?

Common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles, lightheadedness, and rare risk of seizure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have been diagnosed with severe depression.

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My main diagnosis is Major Depressive Disorder.

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I have tried at least 2 antidepressants without success.

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My condition did not improve after treatments from two different types of medication.

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I am receiving two or more recommended treatments (not including benzodiazepines).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing psychotic symptoms during my current depressive episode.

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I am able to understand and give consent for my treatment.

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I have an infection or poor skin condition on my scalp.

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I have a neurological condition like epilepsy or a history of severe head trauma.

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I do not have any magnetic-sensitive implants within 30 cm of my head.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week per subject (three rf measurements will happen within 1 week)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week per subject (three rf measurements will happen within 1 week)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week per subject (three rf measurements will happen within 1 week) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in Electroencephalograms (EEG) functional connectivity

Percent overlap between spatial maps of source-localized EEG connectivity and fMRI-based MDD-rTMS responsive network

Repeatability of the Resonant Frequency measure

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental RFExperimental Treatment1 Intervention

All participants will then undergo six 3000-pulse rTMS "treatment" sessions: two at RFMAX (or rTMSRF-MAX), two at RFMIN (or rTMSRF-MIN), and two at 10 Hz in random order.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation

2017

Completed Phase 4

~730

0 / 11Eligibility criteria met