Self-regulation of Prefrontal Cortex During Emotional Cognitive Control

NCT ID: NCT04543500

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2022-04-16

Brief Summary

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Deficits in emotional cognitive control are present in a number of clinical psychiatric populations including depression, anxiety, and PTSD. Deficits in this domain of function limit one's ability to focus attention on goal directed activities while inhibiting reactions to irrelevant emotional stimuli, and this contributes to the symptoms of these disorders and makes individuals less likely to be successful in existing treatments. The left dorsolateral prefrontal cortex (LDLPFC) and its connectivity with other regions (i.e., dorsal anterior cingulate cortex, ventromedial prefrontal cortex, insula, amygdala) is thought to play a central role in facilitating emotional cognitive control. However, past research has primarily utilized correlational approaches that limit conclusions about the directionality of these relationships. Enhancing our understanding of the neural underpinnings of emotional cognitive control could be valuable for informing treatment for populations with deficits in these processes.

The current study utilizes a neuromodulatory approach called real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) whereby participants observe their own neural activity in the moment and are taught to self-regulate this activity. Healthy adult participants will be trained to increase neural activity in LDLPFC while involved in mental tasks involving emotional cognitive control processes. The mental tasks will include counting, remembering words, or planning events while viewing negatively-valenced emotional words (e.g., kill, death, threat). This study will use an experimental approach with participants being randomized to either LDLPFC rtfMRI-nf or control rtfMRI-nf where participants receive neural feedback from a region not involved with emotional cognitive control processes. Resting-state fMRI scans and behavioral testing sessions will take place before and after rtfMRI-nf.

The specific aims are to examine the impact of LDLPFC rtfMRI-nf on: (1) LDLPFC activity during emotional cognitive control and (2) LDLPFC functional connectivity with other brain regions during rest. Additionally, this study will examine the neural correlates of emotional cognitive control independent of rtfMRI-nf. Thus, the final specific aim is to (3) Investigate relationships between individual differences in LDLPFC engagement, cognitive control performance, trauma history, and sleep quality. To facilitate the relevance of these findings to clinical populations, trauma exposure and sleep quality will be explored as moderators of neural change across time for those in the rtfMRI-nf group.

To these ends, this study will use rtfMRI-nf to experimentally investigate the relationship between LDLPFC activity and emotional cognitive control as well as investigate these neural mechanisms independent of rtfMRI-nf. This research will improve our understanding of emotional cognitive control and demonstrate whether this is a modifiable target for intervention in populations with deficits in this domain of function.

Detailed Description

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Conditions

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Healthy Volunteers Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Left Dorsolateral Prefrontal Cortex rtfMRI-nf

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) will target left dorsolateral prefrontal cortex. Participants in this arm will receive active feedback while attempting to modulate their neural activity during an emotional cognitive control task.

Group Type EXPERIMENTAL

Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)

Intervention Type OTHER

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task.

Sham Left Dorsolateral Prefrontal Cortex rtfMRI-nf

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) will target left postcentral gyrus. Participants in this arm will receive sham feedback while attempting to modulate their neural activity during an emotional cognitive control task.

Group Type ACTIVE_COMPARATOR

Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)

Intervention Type OTHER

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task.

Interventions

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Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* able to provide informed consent
* sufficient English proficiency to complete procedures
* absence of any DSM-5 psychiatric disorder

Exclusion Criteria

* meeting criteria for any DSM-5 psychiatric disorder
* current prescription of psychiatric medication
* history of moderate to severe traumatic brain injury
* diagnosis of neurologic disorders
* current alcohol/drug abuse
* MRI contra-indications (e.g., metal in body)
* uncorrected vision/hearing problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Laureate Institute for Brain Research, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Robin Aupperle

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robin L Aupperle, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Laureate Institute for Brain Research

Locations

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Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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F31MH122090

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-012

Identifier Type: -

Identifier Source: org_study_id

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