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NCT Number: NCT06748976

Modulation of Cortical Brain Activity During Attentional Control

The goal of this study is to determine whether an open-loop sham neurofeedback system can effectively modulate EEG alpha rhythms, which are associated with attentional control. The main questions it aims to answer are:

Does positive sham neurofeedback lead to a decrease in relative EEG alpha power compared to a control condition without feedback?

Researchers will compare the effects of positive and negative sham-neurofeedback conditions to a control condition without feedback to assess the system's impact on alpha rhythm modulation. Participants will:

Experience three conditions (positive sham-neurofeedback, negative sham-neurofeedback, and no feedback) within a virtual reality environment.

Undergo EEG recordings to measure changes in alpha power as a marker of attentional resource allocation.

Provide written informed consent and complete the study following ethical guidelines.

This study seeks to explore the potential of open-loop feedback systems to enhance attentional control by modulating alpha rhythm.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Facultad de Ingeniería, Universidad Nacional de Entre Ríos

Oro Verde, Entre Ríos Province, 3100, Argentina

Location status: Recruiting

Location contact

José Alberto Biurrun Manresa, PhD

CONTACT

[email protected]

+543434975100

José Alberto Biurrun Manresa, PhD

PRINCIPAL_INVESTIGATOR

About this study

Attention is a vital cognitive process that enables selective focus on behaviourally relevant information. A perceived lack of attentional control has been linked to mental disorders such as depression and anxiety, often manifesting through maladaptive coping strategies like rumination. As a trainable cognitive skill, attentional control can be enhanced through learning processes, particularly when reinforced by positive feedback within a classical operant conditioning framework. EEG studies have demonstrated that decreases in alpha rhythm power are associated with increased attentional resource allocation. While neurofeedback systems, especially those targeting alpha rhythms, typically rely on closed-loop modulation during attentional tasks, the impact of open-loop feedback on EEG alpha modulation remains unexplored. This study aims to determine whether an open-loop feedback system can effectively modulate EEG alpha rhythms, as a marker correlate of attentional control. The investigators propose a within-subject experiment where participants will experience positive and negative sham neurofeedback conditions, as well as a control condition with no feedback, all within a virtual reality environment. The investigators hypothesize that relative EEG alpha power will decrease in the positive sham neurofeedback condition compared to the control condition, reflecting a meaningful increase in attentional resource allocation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults aged between 18 and 60 years.
  • Normal or corrected vision.
  • Ability to provide written informed consent.

Exclusion criteria

  • Diagnosed with photosensitive epilepsy.
  • Significant hearing loss or diagnosed hearing impairment.
  • Current psychiatric illness or disorder.
  • History of migraines or chronic headaches.
  • History of substance or alcohol abuse.
  • Currently pregnant.
  • Discomfort with using a virtual reality headset, assessed during a pilot session.

Treatment and study plan

Positive sham neurofeedback

Other

Participants receive simulated positive reinforcement feedback designed to mimic successful modulation of EEG alpha rhythms, despite the feedback not being directly based on their actual neural activity. This condition aims to create the perception of improved attentional control.

Negative sham neurofeedback

Other

Participants receive simulated negative reinforcement feedback that mimics unsuccessful modulation of EEG alpha rhythms, regardless of their actual neural activity. This condition is intended to simulate reduced attentional control.

Control

Other

Participants perform the same attentional task but without receiving any feedback. This condition serves as a baseline to evaluate the effects of the sham neurofeedback interventions on EEG alpha rhythm modulation.

Primary outcomes

  1. Relative alpha power

    Time frame: Immediately after intervention

    The primary outcome of the study is the change in relative EEG alpha power during the positive sham-neurofeedback condition compared to the control condition (no feedback). A decrease in relative alpha power is interpreted as an indicator of increased attentional resource allocation, reflecting enhanced attentional control. This measure is derived from EEG recordings captured during the experimental tasks in each condition.

Secondary outcomes

  1. Relative alpha power

    Time frame: Immediately after intervention

    The secondary outcome of the study is the change in relative EEG alpha power during the negative sham-neurofeedback condition compared to the control condition (no feedback).

Study contacts

Contact information is provided by the study sponsor or research team.

José Alberto Biurrun Manresa, PhD

CONTACT

[email protected]

+543434975100120

Sponsors and collaborators

Lead sponsor

National Council of Scientific and Technical Research, Argentina

Other Gov

Registry information

Official study title

EEG Alpha Rhythm Modulation Using Sham Neurofeedback During Attentional Control in a Virtual Reality Environment

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Sep 25, 2025

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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