Clinical trial NCT04543500: Self-regulation of Prefrontal Cortex During Emotional Cognitive Control
Official title: Self-regulation of Prefrontal Cortex During Emotional Cognitive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Cognitive Function
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-09-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left dorsolateral prefrontal cortex activity during emotional cognitive control (pre- to post-neurofeedback)
timeFrame: Approximately 2 hours after baseline assessment
Secondary outcomes:
measure: Left dorsolateral prefrontal cortex functional connectivity with other brain regions during rest (pre- to post-neurofeedback)
timeFrame: Approximately 2 hours after baseline assessment
Other outcomes:
measure: Emotional Stroop Average Reaction Time
timeFrame: Approximately 1 day after baseline assessment.
measure: Color Word Stroop Average Reaction Time
timeFrame: Approximately 1 day after baseline assessment.
measure: Flanker Task Average Reaction Time
timeFrame: Approximately 1 day after baseline assessment.
measure: Emotional Stroop Reaction Time Difference
timeFrame: Approximately 1 day after baseline assessment.
measure: Color Word Stroop Reaction Time Difference
timeFrame: Approximately 1 day after baseline assessment.
measure: Flanker task Reaction Time Difference
timeFrame: Approximately 1 day after baseline assessment.
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Robin L Aupperle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: