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NCT04543500 · ClinicalTrials.gov registry record · NA

Self-regulation of Prefrontal Cortex During Emotional Cognitive Control

A NA study of Healthy Volunteers and Cognitive Function, sponsored by Laureate Institute for Brain Research.

Completed
Registry status
NA
Development phase
70
Enrollment target
1
Study location

NCT04543500: Completed NA study of Healthy Volunteers and Cognitive Function, sponsored by Laureate Institute for Brain Research.

NCT04543500 is a NA study of Healthy Volunteers and Cognitive Function that has completed, run by Laureate Institute for Brain Research. The registered enrollment target is 70 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04543500, a NA study of Healthy Volunteers and Cognitive Function, has completed, sponsored by Laureate Institute for Brain Research.

COMPLETED
Registry status
NA
Development phase
70 participants
Enrollment target
1
Study location

Study 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

Primary Outcome

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.

Interventions

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

Study Locations (1)

Oklahoma

  • Laureate Institute for Brain Research - Tulsa

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2020-10-28
Est. Completion 2022-04-16
Phase NA

What the finished NCT04543500 record still lists

NCT04543500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (85% lower).

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Real-time functional magnetic resonance neurofeedback (rtfMRI-nf) is the first listed.

NCT04543500 reports a single indexed study location in Oklahoma.

Frequently Asked Questions

What is clinical trial NCT04543500 about?

NCT04543500 is a clinical study titled "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 stimu...

What is the current status of trial NCT04543500?

This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2020-10-28. Estimated completion is 2022-04-16.

What conditions does trial NCT04543500 study?

This clinical trial studies the following conditions: Healthy Volunteers, Cognitive Function.

What interventions are being tested in trial NCT04543500?

The interventions under investigation include: Real-time functional magnetic resonance neurofeedback (rtfMRI-nf) (OTHER).

Who is sponsoring clinical trial NCT04543500?

This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04543500 being conducted?

This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy Volunteers

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04543500's enrollment target sits among peer trials

70 95th of 283 higher than 187 of 283 other Healthy Volunteers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04543500, the US trial registry maintained by the National Library of Medicine. NCT04543500 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.