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Transcranial Magnetic Stimulation

Accelerated TMS for Depression

N/A

Recruiting

Led By David Spiegel, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

TMS naive.

Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).

Must not have

Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS-S score.

Any history of ECT (greater than 8 sessions) without meeting responder criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (day 3) and at immediate post-treatment follow up visit (day 8).

Summary

This trial will evaluate if an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device can help treat people with depression that has not responded to other treatments.

Who is the study for?

This trial is for adults aged 22-65 with treatment-resistant depression, who haven't tried TMS before. They must be able to understand English, have a stable antidepressant regimen, and not plan on pregnancy. Exclusions include unstable symptoms, certain psychiatric conditions like bipolar disorder or severe personality disorders, substance abuse issues, contraindications to MRI or rTMS (like metal in the head), and recent use of rapid acting antidepressants.

What is being tested?

The study tests an accelerated form of theta-burst stimulation via transcranial magnetic stimulation (TBS-DLPFC) against a sham procedure in people with major depressive disorder. Participants are randomly assigned to either real or fake treatments without knowing which one they're getting.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms of facial muscles. There's also a rare risk of seizure associated with TMS procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have never undergone TMS therapy.

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I have been diagnosed with Major Depressive Disorder.

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I am between 22 and 65 years old.

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My medical records show I have hard-to-treat depression, as scored by a specific test.

Exclusion Criteria

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

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My mood symptoms have not worsened by 30% or more recently.

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I've had more than 8 ECT sessions without improvement.

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I have a history of serious brain or nerve conditions.

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My treatment's intensity is more than 65% of the maximum level.

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I have a hormone-related condition that is untreated or not fully treated.

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I do not have metal implants in my head, a history of seizures, or known brain lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (day 3) and at immediate post-treatment follow up visit (day 8).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (day 3) and at immediate post-treatment follow up visit (day 8).

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (day 3) and at immediate post-treatment follow up visit (day 8). 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 in resting state functional connectivity of the subgenual anterior cingulate cortex (sgACC) and the default mode network (DMN).

Secondary study objectives

Relationship between acute mood state and resting state functional connectivity between the sgACC and DMN in active vs. sham participants.

Relationship between clinical improvement and resting state functional connectivity between the sgACC and DMN in active vs. sham participants.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TBS-DLPFCExperimental Treatment1 Intervention

The active group will receive theta-burst TMS stimulation.

Group II: Sham TBS-DLPFCPlacebo Group1 Intervention

The sham group will receive sham theta-burst TMS stimulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active TBS-DLPFC

2017

N/A

~30

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,489 Previous Clinical Trials

17,516,894 Total Patients Enrolled

Nolan Williams, MDStudy DirectorStanford University

17 Previous Clinical Trials

1,182 Total Patients Enrolled

David Spiegel, MD3.73 ReviewsPrincipal Investigator - Stanford University

Stanford University

11 Previous Clinical Trials

1,717 Total Patients Enrolled

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