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NCT04138680 · ClinicalTrials.gov registry record · NA
Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 79
- Enrollment target
NCT04138680: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT04138680 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04138680, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
Study Summary
Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type of cognitive training that includes real-time feedback about brain signal levels from the VTA. Our question is whether VTA self-modulation with biofeedback can influence depression symptoms.
Primary Outcome
For each subject, the % increase in VTA activation during MOTIVATE trails at post-training compared to pre-training will be computed (\[MOTIVATEpost\>RESTpost\] \> \[MOTIVATEpre\>RESTpre\]), indicating the efficacy of training on VTA activity self- regulation. This measure of VTA activity self-regulation from pre to post training will be entered into an independent samples t-test to compare between active and control feedback groups.
Interventions
- BEHAVIORAL Active Biofeedback
- BEHAVIORAL Sham Biofeedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2024-06-11 |
| Phase | NA |
What the finished NCT04138680 record still lists
NCT04138680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Active Biofeedback is the first listed.
NCT04138680 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04138680 about?
NCT04138680 is a clinical study titled "Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression". Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type ...
What is the current status of trial NCT04138680?
This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2019-10-09. Estimated completion is 2024-06-11.
What interventions are being tested in trial NCT04138680?
The interventions under investigation include: Active Biofeedback (BEHAVIORAL), Sham Biofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT04138680?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04138680's enrollment target sits among peer trials
79 1060th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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