Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG for Major Depressive Disorder (MDD)

The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (major depression). This is a feasibility study to test a "closed-loop" procedure which guides the timing of this FDA-cleared form of TMS.

Official registry: https://clinicaltrials.gov/study/NCT07862205 · Mayo Clinic · enrollment listed as 60

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG. The registry lists allocation as randomized. The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (major depression).

They plan to enroll about 60 people at Rochester. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study for Advanced Treatment Outcomes in Adults With Major Depressive Disorder

Interventions: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG

Primary outcome (registry wording): Feasibility of closed-loop EEG guided iTBS in adult participants with MDD.

Who it is for (from inclusion criteria)

  • Ages 22 Years to 60 Years
  • Voluntary patient seeking treatment with the capacity to consent
  • Have Major Depressive Disorder (major depression) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57
  • Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable
  • Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS
  • In a current episode of major depression with duration of at least 4 weeks but less than 2 years
  • Have no initiation or dose change in any psychotropic medication or for the 4 weeks prior to screening
  • Have no clinically significant changes (as determined by the study investigators) in psychotherapeutic interventions for the 4 weeks prior to screening Can safely undergo TMS treatment based on the TMS Adult Safety Screen questionnaire

Public study contact (from the registry)

Courtney Caves

507-255-0624

wolf.courtney@mayo.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07862205 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07862205?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07862205?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary