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Completed

NCT Number: NCT04543500

Self-regulation of Prefrontal Cortex During Emotional Cognitive Control

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Approximately 2 hours after baseline assessment

    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.

Secondary outcomes

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

    Time frame: Approximately 2 hours after baseline assessment

    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.

Other outcomes

  1. Emotional Stroop Average Reaction Time

    Time frame: Approximately 1 day after baseline assessment.

    Average reaction time on the emotion condition of the emotional Stroop task.

  2. Color Word Stroop Average Reaction Time

    Time frame: Approximately 1 day after baseline assessment.

    Average reaction time on the inhibition condition of the color word Stroop task.

  3. Flanker Task Average Reaction Time

    Time frame: Approximately 1 day after baseline assessment.

    Average reaction time on the incongruent condition of the Flanker task.

  4. Emotional Stroop Reaction Time Difference

    Time frame: Approximately 1 day after baseline assessment.

    Difference in reaction time for emotional versus neutral conditions of the emotional Stroop task.

  5. Color Word Stroop Reaction Time Difference

    Time frame: Approximately 1 day after baseline assessment.

    Difference in reaction time for inhibition versus reading conditions of the emotional Stroop task.

  6. Flanker task Reaction Time Difference

    Time frame: Approximately 1 day after baseline assessment.

    Difference in reaction time for incongruent versus congruent conditions of the Flanker task.

Sponsors and collaborators

Lead sponsor

Laureate Institute for Brain Research, Inc.

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: SPrC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2020
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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