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Device

Virtual Reality-Guided TMS for Depression

N/A
Recruiting
Research Sponsored by Soterix Medical
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 below
Select...
My depression hasn't improved after trying two or more treatments and TMS.
Select...
I have been diagnosed with major depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 times per week from baseline until week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 times per week from baseline until week 6 for reporting.

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 more

Trial 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?

Soterix MedicalLead Sponsor
10 Previous Clinical Trials
380 Total Patients Enrolled
Columbia UniversityOTHER
1,426 Previous Clinical Trials
2,473,796 Total Patients Enrolled

Media Library

Neuro-navigated Transcranial Magnetic Stimulation (TMS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04956081 — N/A
Major Depressive Disorder Research Study Groups: virtual neuro-navigation, on-line neuro-navigation
Major Depressive Disorder Clinical Trial 2023: Neuro-navigated Transcranial Magnetic Stimulation (TMS) Highlights & Side Effects. Trial Name: NCT04956081 — N/A
Neuro-navigated Transcranial Magnetic Stimulation (TMS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04956081 — N/A
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04956081 — N/A

Frequently Asked Questions

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

Does the clinical trial accept individuals aged 60 and over?

"Within the parameters of 18-60 years old, this trial is open to suitable candidates."

Answered by AI

To what extent could Neuro-navigated Transcranial Magnetic Stimulation (TMS) be a hazard to patients?

"Our team at Power has deemed the safety profile of Neuro-navigated Transcranial magnetic stimulation (TMS) to be a score 1, as data backing up its security and effectiveness is only preliminary."

Answered by AI

What is the aggregate amount of individuals taking part in this experiment?

"Affirmative. According to clinicaltrials.gov, this scientific trial is actively recruiting patients since its initial posting on July 1st 2021 and most recent update on April 13th 2022. Currently the research team seeks 12 participants from a single medical centre."

Answered by AI

Are there currently openings for participants in this investigation?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical research, which was initially published on the first of July 2021, is actively searching for participants. For the trial to be successful 12 people must enroll in the single location it has been assigned to."

Answered by AI

Who is eligible to join this clinical research?

"To be considered for this clinical trial, participants must have unipolar depression and reside between the ages of 18 to 60. A maximum of 12 people are being enrolled at this time."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
New York
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Columbia Docs
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have spent most of my adult life on various antidepressants. I can act like I’m ok and I’m great at making excuses why I can’t be somewhere when the truth is, I would always rather go back to sleep. I want to stop flaking on friends and get out of bed.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 1 Day
Most responsive sites:
  1. Columbia Docs: < 24 hours
~5 spots leftby Jan 2026