Self-regulation of Prefrontal Cortex During Emotional Cognitive Control

Healthy Volunteers Clinical Trial

— SPrC  

Official title:

Self-regulation of Prefrontal Cortex During Emotional Cognitive Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543500
• Other study ID #: 2019-012
• Secondary ID: F31MH122090
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: April 16, 2022

Study information

• Verified date: August 2022
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 16, 2022
• Est. primary completion date: April 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function
• Healthy Volunteers

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotional Stroop Average Reaction Time	Average reaction time on the emotion condition of the emotional Stroop task.	Approximately 1 day after baseline assessment.
Other	Color Word Stroop Average Reaction Time	Average reaction time on the inhibition condition of the color word Stroop task.	Approximately 1 day after baseline assessment.
Other	Flanker Task Average Reaction Time	Average reaction time on the incongruent condition of the Flanker task.	Approximately 1 day after baseline assessment.
Other	Emotional Stroop Reaction Time Difference	Difference in reaction time for emotional versus neutral conditions of the emotional Stroop task.	Approximately 1 day after baseline assessment.
Other	Color Word Stroop Reaction Time Difference	Difference in reaction time for inhibition versus reading conditions of the emotional Stroop task.	Approximately 1 day after baseline assessment.
Other	Flanker task Reaction Time Difference	Difference in reaction time for incongruent versus congruent conditions of the Flanker task.	Approximately 1 day after baseline assessment.
Primary	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	Left dorsolateral prefrontal cortex functional connectivity with other brain regions during rest (pre- to post-neurofeedback)	Individual functional connectivity values between left dorsolateral prefrontal cortex and other brain regions during rest will be assessed before and after neurofeedback for both active and sham conditions.	Approximately 2 hours after baseline assessment