Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-28 @ 4:42 AM
Study NCT ID:
NCT06132659
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2023-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neurofeedback Enhanced Cognitive Reappraisal Training
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Neurofeedback Enhanced Cognitive Reappraisal Training
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to understand emotion regulation in those with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback.
The study hypotheses include:
* Participants receiving veritable-Neurofeedback (NF) will show a greater activation increase in the prefrontal cortex (PFC) compared to sham-NF
* Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF
* Prefrontal cortex activation will positively correlate with CR ability
The study hypotheses include:
* Participants receiving veritable-Neurofeedback (NF) will show a greater activation increase in the prefrontal cortex (PFC) compared to sham-NF
* Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF
* Prefrontal cortex activation will positively correlate with CR ability
Detailed Description:
Due to an unforeseen error in our online neurofeedback script, in which the location of the brain region being targeted was not properly read by the script, participants in the veritable-NF group received feedback to the medial parietal cortex (MPC) instead of the PFC. A third, unrandomized arm has been added to this registration to enroll an additional subset of participants who are indeed receiving feedback to the PFC. The pre-existing veritable-NF arm has been relabeled to reflect which region of the brain was actually targeted. Additionally, the masking description has been reset to "None".
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: