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Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback

StatusCompleted
PhaseNot applicable
Started2024-03-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-30
notable
Trial completed
Final enrollment: 45 participants (planned 58)
Primary completion confirmed: July 2026 (last estimated September 2026)
2026-06-04
minor
Study Status v8
Primary completion date2026-09→2026-09-01
Completion date2026-09→2026-09-01
2026-05-27
minor
Study Status, Oversight, Study Design v7
Enrollment target70→58
2025-10-02
minor
Study Identification, Study Status, Arms and Interventions, Contacts/Locations v6
Primary completion date2025-09→2026-09
Completion date2025-09→2026-09
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Targeting Large-scale Networks in Depression withWith Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
2025-02-28
minor
Study Identification, Study Status, Oversight, Arms and Interventions, Contacts/Locations v5
Primary completion date2025-12→2025-09
Completion date2025-12→2025-09
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Targeting Large-scale Networks in Depression Withwith Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
Show 4 earlier versions
2024-03-18
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-03→confirmed 2024-03-18
Study sitesdetails revised at 1 of 1 site
2024-02-02
minor
Study Status v3
Start date2024-01→2024-03
2023-12-06
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description v2
Start date2023-12→2024-01
Study description-2 characters
Part 3/Phase 3 study hypothesis are: RecallRest StopFocus Task (RSTRFT) will activate brain networks at the individual subject lev [...] a viable signal for Neurofeedback (NF) At the group level, RSTRFT in the Active>Passive contrast will activate canonically de [...] feedback-reinforced practice over the session will increase RSTRFT activation over the course of the training session, comparing RSTRFT activation, without NF, before and after NF runs. Valid Neurofeedback will increase RSTRFT activation more compared to sham NF (assessed during the no-NF session).
Collaborators+42 characters
National Institute of Mental Health (NIMH)
2023-10-05
minor
Study Status v1
Re-verified, no change to tracked fields
2023-09-16
minor
Original filing
The purpose of this study is to develop a technique called real time fMRI neurofeedback. This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms. This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. Phase 2 (part 2) was registered and is NCT05934604. This is the phase 3 (part 3) for this project and is funded by the National Institutes of Health.
Trial Details
NCT Number NCT06050070
Lead Sponsor University of Michigan
Collaborators: National Institute of Mental Health (NIMH)
Conditions Major Depressive Disorder
Enrollment 45 participants
Start Date 2024-03-18
Primary Completion 2026-07-07 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-29