Modulation of Cortical Brain Activity During Attentional Control

NCT ID: NCT06748976

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rumination Chronic Pain Fibromyalgia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy

Volunteers: Adults aged 18-60 years with normal or corrected vision, no clinical history of photosensitive epilepsy, psychiatric disorders, significant hearing loss, migraines, or substance abuse.

Interventions:

Positive sham-neurofeedback Negative sham-neurofeedback Control (no feedback)

Positive sham neurofeedback

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Positive sham neurofeedback

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.

Intervention Type OTHER

Negative sham neurofeedback

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.

Intervention Type OTHER

Control

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Council of Scientific and Technical Research, Argentina

OTHER_GOV

Sponsor Role lead

Responsible Party

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José Biurrun Manresa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Facultad de Ingeniería, Universidad Nacional de Entre Ríos

Oro Verde, Entre Ríos Province, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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José Alberto Biurrun Manresa, PhD

Role: CONTACT

+543434975100120

Facility Contacts

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José Alberto Biurrun Manresa, PhD

Role: primary

+543434975100

References

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Knowles MM, Wells A. Single Dose of the Attention Training Technique Increases Resting Alpha and Beta-Oscillations in Frontoparietal Brain Networks: A Randomized Controlled Comparison. Front Psychol. 2018 Sep 20;9:1768. doi: 10.3389/fpsyg.2018.01768. eCollection 2018.

Reference Type BACKGROUND
PMID: 30294294 (View on PubMed)

Magosso E, Ricci G, Ursino M. Modulation of brain alpha rhythm and heart rate variability by attention-related mechanisms. AIMS Neurosci. 2019 Mar 4;6(1):1-24. doi: 10.3934/Neuroscience.2019.1.1. eCollection 2019.

Reference Type BACKGROUND
PMID: 32341965 (View on PubMed)

Enriquez-Geppert S, Smit D, Pimenta MG, Arns M. Neurofeedback as a Treatment Intervention in ADHD: Current Evidence and Practice. Curr Psychiatry Rep. 2019 May 28;21(6):46. doi: 10.1007/s11920-019-1021-4.

Reference Type BACKGROUND
PMID: 31139966 (View on PubMed)

Other Identifiers

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IS004817

Identifier Type: -

Identifier Source: org_study_id

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