Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05855525 |
| Other study ID # |
2208009393 |
| Secondary ID |
1R21MH129630-01A |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2024 |
| Est. completion date |
March 31, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Drexel University |
| Contact |
Aaron Kucyi, PhD |
| Phone |
2155537124 |
| Email |
aaron.kucyi[@]drexel.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
