MagVenture MagPro System with Brainsight neuronavigation device for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Weill Cornell Medicine, New York, NYDepression+1 MoreMagVenture MagPro System with Brainsight neuronavigation device - Device
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new accelerated 5-day rTMS protocol for treating symptoms of depression and OCD. The goal is to improve symptoms and identify biomarkers for depression and OCD.

Eligible Conditions
  • Depression
  • Obsessive-Compulsive Disorder

Treatment Effectiveness

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Baseline to Treatment End: Day 5, 10, 15, or 20 (depending on number of 5-day treatment courses administered)

Day 5
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores for participants with treatment resistant depression
Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with OCD
Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with treatment resistant depression
Percent Change in 17-item Hamilton Depression Rating Scale (HAM-D) scores for participants with treatment resistant depression
Percent Change in Beck Anxiety Inventory (BAI) scores for participants with OCD
Percent Change in Beck Depression Inventory (BDI) scores for participants with OCD
Mental Depression
Percent Change in General Anxiety Disorder (GAD-7) scores for participants with OCD
Percent Change in Patient Health Questionnaire (PHQ-9) scores for participants with OCD
Percent Change in Patient Health Questionnaire-9 (PHQ-9) scores for participants with OCD
Percent Change in Quick Inventory of Depressive Symptomatology (QIDS) scores for participants with OCD
Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD

Trial Safety

Trial Design

4 Treatment Groups

OCD - LPFC target to (for non-responders) DMPFC target
1 of 4
Depression - LPFC target to (for non-responders) DMPFC target
1 of 4
Depression - DMPFC target to (for non-responders) LPFC target
1 of 4
OCD - DMPFC target to (for non-responders) LPFC target
1 of 4

Active Control

Experimental Treatment

300 Total Participants · 4 Treatment Groups

Primary Treatment: MagVenture MagPro System with Brainsight neuronavigation device · No Placebo Group · N/A

Depression - DMPFC target to (for non-responders) LPFC target
Device
Experimental Group · 1 Intervention: MagVenture MagPro System with Brainsight neuronavigation device · Intervention Types: Device
OCD - DMPFC target to (for non-responders) LPFC target
Device
Experimental Group · 1 Intervention: MagVenture MagPro System with Brainsight neuronavigation device · Intervention Types: Device
OCD - LPFC target to (for non-responders) DMPFC target
Device
ActiveComparator Group · 1 Intervention: MagVenture MagPro System with Brainsight neuronavigation device · Intervention Types: Device
Depression - LPFC target to (for non-responders) DMPFC target
Device
ActiveComparator Group · 1 Intervention: MagVenture MagPro System with Brainsight neuronavigation device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to treatment end: day 5, 10, 15, or 20 (depending on number of 5-day treatment courses administered)

Who is running the clinical trial?

The Wellcome Leap FundUNKNOWN
The New Venture Fund / Foundation for OCD ResearchUNKNOWN
Weill Medical College of Cornell UniversityLead Sponsor
997 Previous Clinical Trials
1,341,655 Total Patients Enrolled
61 Trials studying Depression
15,542 Patients Enrolled for Depression
Conor Liston, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
348 Total Patients Enrolled
1 Trials studying Depression
348 Patients Enrolled for Depression

Eligibility Criteria

Age 18 - 70 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with either major depressive disorder or obsessive-compulsive disorder, based on the DSM-V criteria.
You have significant symptoms of depression or obsessive-compulsive disorder based on a standardized test.

Who else is applying?

What state do they live in?
New York83.3%
Quebec16.7%
How old are they?
18 - 65100.0%
What site did they apply to?
Weill Cornell Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%

Frequently Asked Questions

What is the sample size of this research study?

"Yes, according to clinicaltrials.gov this medical research is presently recruiting patients. Initially posted on August 18th 2021 and last edited June 27th 2022, the study seeks 300 participants at a single site." - Anonymous Online Contributor

Unverified Answer

What are the eligibility requirements for participation in this research project?

"This clinical trial, which is open to adults aged 18-70 with depression and OCD, seeks 300 participants. The necessary criteria for enrolment include a failure of current treatment despite adequate dosing; DSM-V diagnosis of major depressions disorder or obsessive compulsive disorder; Hamilton Depression Rating Scale score greater than 18 OR Yale-Brown Obsessive Compulsive Scale score higher than 16; stable dose of antidepressants for at least 4 weeks with plans to remain on this dosage during the study; and capacity to give informed consent." - Anonymous Online Contributor

Unverified Answer

Does this trial accept senior citizens as participants?

"This medical trial is open to patients who are 18 years or older, but not yet 70." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities available to participate in this medical experiment?

"Per the clinicaltrials.gov registry, this research is actively recruiting patient populations; the study was first advertised on August 18th 2021 and underwent its latest update June 27th 2022." - Anonymous Online Contributor

Unverified Answer

What are the key objectives of this experimental procedure?

"Over the Baseline to Treatment End: Day 5, 10, 15 or 20 (depending on number of courses administered) period for this trial, investigators will assess the Percent Change in Yale-Brown Obsessive Compulsive Scale scores. Additionally, they shall measure the change in Beck Anxiety Inventory results (ranging from 0 - 63), General Anxiety Disorder rankings (from 0 - 21), and resting-state fMRI connectivity between frontostriatal network and limbic network (between 0 - 1)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.