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Rapid-Acting TMS for Depression
Study Summary
This trial is testing if a new, accelerated schedule of transcranial magnetic stimulation (TMS) can help people with depression who haven't responded to other treatments. TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your depression score is 20 or higher during the first visit of the study.I can get rTMS treatment after the study ends.I have a stable anxiety disorder but no other major psychiatric conditions needing treatment.You have received any experimental medications or treatments during the study timeframe.I have a history of serious brain or nerve conditions.I do not have metal implants in my head, a history of seizures, or known brain lesions.I can get rTMS treatment after the study ends.I have ongoing mental health support available before and after the study.I can speak and understand English well enough to follow study instructions and fill out questionnaires.My depression symptoms have not worsened by 30% or more recently.My treatment's intensity is more than 65% of the maximum level.My medical records show I have hard-to-treat depression.Do not drink alcohol for one day before each MRI and TMS session.I've had more than 8 ECT sessions without improvement.You can continue to drink coffee, tea, cola, and eat chocolate as you normally would during the study.You are currently struggling with a serious drug or alcohol problem or experiencing withdrawal symptoms.You have been diagnosed with a learning disability or autism.I have been diagnosed with Major Depressive Disorder.You have had thoughts of hurting yourself or have attempted suicide within the past year.I have a hormone-related condition that is untreated or not fully treated.I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.I have been diagnosed with Major Depressive Disorder.I have never undergone TMS therapy.You have a history of or currently have a mental health condition called psychosis or bipolar disorder.I am between 22 and 65 years old.I have never undergone TMS therapy.You have a severe form of borderline personality disorder.I have used ketamine or had ECT for depression within the last 4 weeks.
- Group 1: Active TBS-DLPFC
- Group 2: Sham TBS-DLPFC
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals have volunteered to partake in this research?
"Affirmative. According to the details hosted on clinicaltrials.gov, this research study is presently seeking participants after being posted on June 15th 2021 and updated most recently in May 5th 2022. 100 individuals need to be enrolled from one medical facility for the trial's completion."
Does the current research have an age ceiling for its participants?
"This trial stipulates that potential participants must fall within a certain age range, with the minimum being 22 and the maximum of 65."
Who is eligible to participate in this research endeavor?
"This clinical trial seeks 100 people, aged between 22 and 65 years old who struggle with depression that is unresponsive to treatment. Necessary criteria for eligibility include: male/female gender identification, the ability to comprehend informed consent documents, fluency in English appropriate for questionnaires and fMRI assessments, diagnosis of Major Depressive Disorder as defined by DSM-5 guidelines along with a MADRS score ≥20 at screening (Visit 1), lack experience with TMS therapy previously, access to psychiatric care both before and after study completion and the availability of rTMS afterwards if needed. Additionally, participants must be on a consistent antidepressant regimen 6 weeks"
Are there open enrollments for this research endeavor?
"Clinicaltrials.gov indicates that this clinical trial is actively searching for participants; the first listing was published on June 15th 2021, and it has been recently revised at May 5 2022."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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