Self-regulation of Prefrontal Cortex During Emotional Cognitive Control

NCT04543500 | Completed

• 2 other identifiers: 2019-012F31MH122090
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Left dorsolateral prefrontal cortex activity during emotional cognitive control (pre- to post-neurofeedback)

  Individual ability to regulate left dorsolateral prefrontal cortex activity during an emotional cognitive control task will be assessed before and after neurofeedback for both active and sham conditions.

  Approximately 2 hours after baseline assessment

Secondary Outcomes (1)

• Left dorsolateral prefrontal cortex functional connectivity with other brain regions during rest (pre- to post-neurofeedback)

  Approximately 2 hours after baseline assessment

Other Outcomes (6)

• Emotional Stroop Average Reaction Time

  Approximately 1 day after baseline assessment.

• Color Word Stroop Average Reaction Time

  Approximately 1 day after baseline assessment.

• Flanker Task Average Reaction Time

  Approximately 1 day after baseline assessment.

Study Arms (2)

Active Left Dorsolateral Prefrontal Cortex rtfMRI-nf

EXPERIMENTAL

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.

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

Sham Left Dorsolateral Prefrontal Cortex rtfMRI-nf

ACTIVE COMPARATOR

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.

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

Interventions

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

Active Left Dorsolateral Prefrontal Cortex rtfMRI-nf; Sham Left Dorsolateral Prefrontal Cortex rtfMRI-nf

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Study Officials

• Robin L Aupperle, Ph.D.

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: October 28, 2020
• Primary Completion: April 16, 2022
• Study Completion: April 16, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)