← Back to Search

Non-Pharmacological Therapy

rTMS for Treatment-Resistant Depression (BioTMS Trial)

Phase 3
Recruiting
Led By Conor Liston, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 22 to 65 years
At least moderately severe depression (17-item Hamilton Depression Rating Scale greater than or equal to 18)
Timeline
Screening 3 weeks
Treatment 6 weeks
Follow Up 8 weeks
Awards & highlights

BioTMS Trial Summary

This trial is testing whether using brain network connectivity patterns can help optimize outcomes from rTMS treatment for depression.

Who is the study for?
Adults aged 22-65 with moderate to severe depression, who haven't improved after trying at least one antidepressant, can join this trial. They must be fluent in English and able to have an MRI safely. Participants should not change their antidepressant dose during the study and must consent to team communication with their clinicians.Check my eligibility
What is being tested?
The trial is testing whether brain scans (fMRI) can help optimize rTMS treatment for depression. It explores how rTMS affects brain networks by using these scans before and after therapy sessions.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. Some people might experience temporary hearing changes due to the noise during treatment.

BioTMS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 22 and 65 years old.
Select...
I have been diagnosed with moderately severe depression.
Select...
My current depression treatment isn't working despite trying at least one medication.
Select...
My depression medication dose has been stable for at least 4 weeks.
Select...
I am able to understand and agree to the study's requirements.
Select...
I am able to understand and agree to the study's requirements.
Select...
I can safely undergo an MRI scan.
Select...
I am between 22 and 65 years old.
Select...
I have been diagnosed with moderately severe depression.
Select...
My depression hasn't improved after trying at least one antidepressant.
Select...
I have not changed my depression medication dose for at least 4 weeks.
Select...
I am able to understand and agree to the study's requirements.
Select...
I am between 22 and 65 years old.
Select...
I have been diagnosed with moderately severe depression.
Select...
My depression didn't improve after trying at least one antidepressant.
Select...
I have not changed my depression medication dose for at least 4 weeks.
Select...
I understand and can agree to medical procedures.
Select...
I can safely undergo an MRI scan.

BioTMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ 6 weeks
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, 6 weeks for treatment, and 8 weeks 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 depression, as measured by the Hamilton Depression Rating Scale (HAMD17)
Secondary outcome measures
Change in Resting State fMRI Connectivity
Change in depression, as measured by the Quick Inventory of Depressive Symptomology (QIDS)

BioTMS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Targeted Side ArmExperimental Treatment1 Intervention
iTBS rTMS targeting the area of the brain (DLPFC or dorsomedial prefrontal cortex DMPFC)) that we hypothesize will be most effective for that subject's biotype (confirmation arm).
Group II: Standard of CareActive Control1 Intervention
FDA-cleared, standard-of-care iTBS repetitive Transcranial Magnetic Stimulation targeting the left dorsolateral prefrontal cortex (DLPFC), regardless of the depression subtype (biotype) determined by a magnetic resonance imaging (MRI) scan.
Group III: Opposite Side ArmActive Control1 Intervention
iTBS rTMS targeting the opposite site (DLPFC or DMPFC) than the one we hypothesize will be most effective for that subject's biotype (disconfirmation arm).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation
2013
Completed Phase 3
~1170

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,408 Total Patients Enrolled
666 Trials studying Depression
251,236 Patients Enrolled for Depression
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,315,981 Total Patients Enrolled
66 Trials studying Depression
16,050 Patients Enrolled for Depression
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,341,272 Total Patients Enrolled
106 Trials studying Depression
93,536 Patients Enrolled for Depression

Media Library

Repetitive Transcranial Magnetic Stimulation (Non-Pharmacological Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04041479 — Phase 3
Depression Research Study Groups: Standard of Care, Targeted Side Arm, Opposite Side Arm
Depression Clinical Trial 2023: Repetitive Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT04041479 — Phase 3
Repetitive Transcranial Magnetic Stimulation (Non-Pharmacological Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04041479 — Phase 3
Depression Patient Testimony for trial: Trial Name: NCT04041479 — Phase 3

Frequently Asked Questions

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

Are new participants being recruited for this experiment?

"That is correct, the listing on clinicaltrials.gov reflects that this research is actively recruiting participants. The study was first posted on September 1st, 2021 and was last updated on June 24th, 2022. The study is looking for 348 patients across 1 location."

Answered by AI

Does the FDA recognize the benefits of Repetitive Transcranial Magnetic Stimulation?

"Repetitive Transcranial magnetic stimulation has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning that there is both some efficacy data as well as multiple rounds of safety data."

Answered by AI

Is this research available to adults of all ages?

"According to the eligibility requirements set out by the researchers, patients must be aged between 22 and 65. Out of the 1294 similar studies, 202 are for patients below the age of 18 and 992 are for patients that are above 65."

Answered by AI

Would I be able to be a subject in this research?

"The eligibility requirements for this study include a formal diagnosis of depression and an age between 22 and 65. With a need for 348 patients in total, this trial has a significant amount of interest."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
California
Other
New York
How old are they?
18 - 65
What site did they apply to?
Stanford University
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

Setaquil ability thorzine l. I have medication resistant depression. You are my doctor's I saw phychiatrist today at 505 70 St.
PatientReceived 2+ prior treatments
I’ve had depression all my life and tried many different drugs. I wish to further research on non- pharma treatment for Depression. And, I wish to be compensated.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Will expenses be paid? Is this trial compensated? What is the duration of the tests?
PatientReceived 1 prior treatment
Is there anything I can do to be a better qualified, or more suitable candidate?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Weill Cornell Medicine: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Biomarker-guided rTMS for Treatment Resistant Depression
2021. "Biomarker-guided rTMS for Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04041479.
All > Depression New York
~146 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top