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Behavioural Intervention

Brain Stimulation Techniques for Depression

N/A

Waitlist Available

Led By Sheldon E Jordan, M.D.

Research Sponsored by Neurological Associates of West Los Angeles

Eligibility Criteria Checklist

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

Must have

At least 18 years of age

Failure to remit with 3 antidepressants

Must not have

Sickle cell disease

Advanced stages of any terminal illness or any active cancer that requires chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of two types of brain stimulation on depression.

Who is the study for?

This trial is for adults with major depressive disorder who haven't improved after trying three antidepressants. Participants must be over 18, speak English, and score above 13 on the Beck Depression Inventory. It's not for those with active cancer, recent surgery, metal implants near the head, or certain blood diseases.

What is being tested?

The study compares two depression treatments: Transcranial Magnetic Stimulation (TMS) and intermittent Theta Burst Stimulation (iTBS). The goal is to see which one works better at improving symptoms of major depressive disorder.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms in facial muscles. Rarely it could cause seizures or hearing loss if proper ear protection isn't used.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have tried 3 antidepressants without improvement.

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I have been diagnosed with Major Depressive Disorder.

Exclusion Criteria

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

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I have sickle cell disease.

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I have an advanced terminal illness or cancer needing chemotherapy.

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I have liver problems.

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I have a rash or open wounds on my scalp.

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I have a neurodegenerative disease.

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I am not proficient in English.

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I have stents in my neck or brain.

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I or my close family member have had epilepsy or seizures.

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I cannot lay still for long periods.

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I have had blood clots in my heart, brain, or limbs.

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I have a disease affecting my bone marrow.

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I am currently receiving treatment for cancer.

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I am at a higher risk of having seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Beck Depression Inventory (BDI-II)

Global Rating of Change (GRC)

Hamilton Depression Rating Scale (HAM-D)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transcranial Magnetic StimulationExperimental Treatment1 Intervention

All patients are required to have an advanced MRI of the brain including a structural T1, volume measurements of various brain regions, ASL, and BOLD sequences. Patients will also undergo an in-scanner task designed to activate key neurofunctional regions of interest.

Group II: Theta Burst StimulationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Theta Burst Stimulation

2014

N/A

~160

Transcranial Magnetic Stimulation

2017

Completed Phase 4