- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855525
Real-time fMRI for Insular Cortex Brain State-triggered Experience Sampling
August 18, 2025 updated by: Drexel University
In a neuroimaging session, study participants will repeatedly and intermittently report the content of their ongoing, self-generated experiences based on an experience-sampling protocol in which self-report ratings will be triggered based on real-time analysis of the participant's current brain state.
The protocol will be conducted while participants are undergoing MRI scanning.
Study Overview
Detailed Description
The investigators will develop a new approach called real-time functional MRI (fMRI)-triggered experience-sampling to efficiently sample spontaneous neural events (of a predefined type) and to map those events to specific qualities of self-generated experiences.
Within 60 healthy adults, the investigators will use online (real-time) fMRI analysis to detect brain activations and trigger the appearance of visual rating scales so that participants can report their experiences immediately after the occurrence of a neural event of interest.
The investigators will develop and validate the approach with a focus on real-time fMRI analysis of the dorsal anterior insular cortex (daIC), a brain region implicated in salience detection that is consistently identified as having aberrant structure, function, and connectivity in psychiatric illness at a transdiagnostic level.
Aim 1 is to determine whether spontaneous daIC activation events are time-locked to instances of salient, high-arousal self-generated experience.
The investigators will sample self-generated experiences both during instances of daIC activation and during baseline (intermediate daIC activity) events.
The investigators hypothesize that daIC activation, relative to baseline events, will be time-locked to self-generated experiences with higher subjective ratings of arousal and vividness (regardless of affective valence).
Aim 2 is to determine how distinct instances of daIC activation are coupled to physiological and whole-brain activity.
Using a hypothesis-driven approach, the investigators will determine whether spontaneous fMRI activations in the daIC are associated with pupil dilation and activation of the locus coeruleus, a subcortical generator of arousal-related neuromodulation.
Additionally, using a more data-driven approach, the investigators will test whether different instances of daIC activation are associated with multiple, distinct whole-brain co-activation patterns, and whether these co-activation patterns are associated with fluctuations in subjective affect (positive vs. negative experiences).
If successful, the protocols can later be applied in patients with psychiatric illness and to potentially guide the development of interventions (e.g., neurostimulation, neurofeedback) that aim to target the neural processes that produce self-generated experiences that are core to mental illness.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tiara Bounyarith, BA
- Phone Number: 2155537124
- Email: tb3344@drexel.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Drexel University
-
Contact:
- Tiara Bounyarith, BA
- Email: tb3344@drexel.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18-35
Exclusion Criteria:
- History of psychiatric or neurological disorder
- contraindication for MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real-time fMRI
Participants will repeatedly and intermittently report the content of their ongoing, self-generated experiences based on an experience-sampling protocol in which self-report ratings will be triggered based on real-time analysis of the participant's current brain state.
The protocol will be conducted while participants are undergoing MRI scanning.
|
Participants will repeatedly and intermittently report the content of their ongoing, self-generated experiences based on an experience-sampling protocol in which self-report ratings will be triggered based on real-time analysis of the participant's current brain state.
The protocol will be conducted while participants are undergoing MRI scanning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants showing an association between self-reported arousal (simple rating scale) and fMRI activation level in anterior insula
Time Frame: Two sessions over one month
|
Participants will rate their subject arousal level on trials that are triggered by anterior insula activation (using real-time fMRI analysis) and control trials not involving anterior insula activation.
The outcome is the number of participants showing an association between self-reported arousal and fMRI activation in anterior insula.
|
Two sessions over one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron Kucyi, PhD, Drexel University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2024
Primary Completion (Estimated)
November 30, 2025
Study Completion (Estimated)
November 30, 2025
Study Registration Dates
First Submitted
March 30, 2023
First Submitted That Met QC Criteria
May 3, 2023
First Posted (Actual)
May 11, 2023
Study Record Updates
Last Update Posted (Actual)
August 22, 2025
Last Update Submitted That Met QC Criteria
August 18, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2208009393
- 1R21MH129630-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data generated from this study will become publicly available.
After de-identifying and anonymizing all neuroimaging and behavioral data, the investigators plan to share data via the National Institute of Mental Health Data Archive.
IPD Sharing Time Frame
Availability: December 2024 until 2030
IPD Sharing Access Criteria
Publicly available
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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