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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Met criteria for treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ, as well as an adequate course of TMS treatment using standard targeting approaches (e.g. 5-cm, 5.5-cm, F3)
DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 times per week from baseline until week 6
Awards & highlights
Study Summary
This trial is testing a new way to use TMS, a treatment for depression, by using a virtual reality system to help guide the treatment.
Who is the study for?
This trial is for adults with major depressive disorder who haven't improved after trying at least two depression treatments and TMS using standard methods. They must have moderate to severe depression, not be claustrophobic, free from psychotic disorders or recent substance abuse, not actively suicidal, able to consent, and not pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests a virtual neuro-navigation system designed to improve the precision of TMS treatment for depression. It's a Phase I trial focusing on how well this new technology identifies specific brain targets to enhance the effectiveness of TMS.See study design
What are the potential side effects?
While side effects are not detailed here, typical TMS side effects can include headache, scalp discomfort during treatment sessions, lightheadedness, and in rare cases seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My depression hasn't improved after trying two or more treatments and TMS.
Select...
I have been diagnosed with major depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 times per week from baseline until week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 times per week from baseline until week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Columbia suicide severity rating scale (C-SSRS)
Concomitant Medication List (CML)
Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)33
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: virtual neuro-navigationExperimental Treatment1 Intervention
The specific area within the L-DLPFC will be identified by a software using MR images. TMS will be administered to the identified area.
Group II: on-line neuro-navigationExperimental Treatment1 Intervention
The specific area within the L-DLPFC will be identified by a person using MR images. TMS will be administered to the identified area.
Find a Location
Who is running the clinical trial?
Columbia UniversityOTHER
1,442 Previous Clinical Trials
2,451,885 Total Patients Enrolled
Soterix MedicalLead Sponsor
10 Previous Clinical Trials
380 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I take medication that doesn't allow me to have TMS treatment.My health is stable; no recent issues found in exams or tests.I did not improve after ECT, VNS, or DBS treatments.My medication doses have been stable for 4 weeks and I agree to keep them the same during the study.I am not pregnant, breastfeeding, and I use birth control or do not plan to become pregnant.I am unable to understand or make decisions about my treatment.My depression hasn't improved after trying two or more treatments and TMS.I have a condition that affects my nerves or muscles.You have had problems with drugs or alcohol in the past six months (or two months if it was not as severe). You have also used drugs through injections in the past.I haven't taken MAOI drugs in the last month.You are currently feeling extremely sad and have thoughts of hurting yourself or a plan to do so.I am taking medication that could increase my risk of seizures.You experience extreme fear or discomfort in small, enclosed spaces.You have received ketamine treatment within the past 6 months.I have not been diagnosed with a psychotic disorder or severe eating disorder in the past year.I have been diagnosed with major depression.
Research Study Groups:
This trial has the following groups:- Group 1: virtual neuro-navigation
- Group 2: on-line neuro-navigation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04956081 — N/A
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