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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
Access to ongoing psychiatric care before and after completion of the study.
Access to clinical rTMS after study completion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (day 3) and at immediate post-treatment follow up visit (day 8).
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 access to psychiatric care before and after the study.
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I can get rTMS treatment after the study ends.
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My medical records show I have moderate to severe treatment-resistant condition.
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I have never undergone TMS therapy.
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I have never undergone TMS therapy.
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I can avoid alcohol for 24 hours before MRI and TMS sessions and understand tobacco use is restricted.
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I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in resting state functional connectivity of the subgenual anterior cingulate cortex (sgACC) and the default mode network (DMN).
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,378 Previous Clinical Trials
17,333,259 Total Patients Enrolled
Nolan Williams, MDStudy DirectorStanford University
16 Previous Clinical Trials
1,132 Total Patients Enrolled
David Spiegel, MD3.73 ReviewsPrincipal Investigator - Stanford University
Stanford University
10 Previous Clinical Trials
1,637 Total Patients Enrolled
1Patient Review
I was very disappointed with my recent experience at this office. I arrived early for my appointment and was informed that the doctor would be running late. I waited for 18 minutes before leaving. I was then called by the doctor and told that I needed to come back. I don't appreciate being treated this way by a professional. I will not be returning.

Media Library

Active TBS-DLPFC (Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04243798 — N/A
Major Depressive Disorder Research Study Groups: Sham TBS-DLPFC, Active TBS-DLPFC
Major Depressive Disorder Clinical Trial 2023: Active TBS-DLPFC Highlights & Side Effects. Trial Name: NCT04243798 — N/A
Active TBS-DLPFC (Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04243798 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial actively seeking participants?

"The clinical trial is actively seeking participants, as reported on the government-hosted website. It was first uploaded to the platform on June 15th 2021 and its information has been updated most recently on May 5th 2022."

Answered by AI

Are persons below the age of sixty capable of participating in this research?

"This medical trial seeks patients aged between 22 and 65. There are 177 studies for those under the legal age of consent and 859 for seniors who exceed that upper limit."

Answered by AI

How many individuals are partaking in this medical experiment?

"Affirmative. Clinicaltrials.gov records show that this clinical trial, which was first published on June 15th 2021, is presently looking for participants. About 100 patients need to be enrolled from a single medical centre."

Answered by AI

Do I meet the criteria to enroll in this experiment?

"This medical study is looking for 100 people who fit the following criteria: has been diagnosed with Major Depressive Disorder, aged between 22 and 65 years old, able to read and comprehend written English instructions, willing to comply with all procedures of the experiment, a history of treatment-resistance as per Maudsley Staging Method (MSM3), MADRS score of 20 or higher at screening visit 1 , no prior experience with TMS treatments , access to ongoing psychiatric care before and after completion of the study , have an active antidepressant therapeutic plan in place 6 weeks prior to enrolment that must be maintained throughout duration of trial,,and"

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
Recent research and studies
~38 spots leftby Dec 2025