Modulation of Cortical Brain Activity During Attentional Control

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Fibromyalgia; Rumination
• Intervention / Treatment: Other: Positive sham neurofeedback; Other: Negative sham neurofeedback; Other: Control

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: José Alberto Biurrun Manresa, PhD; Phone Number: +543434975100120; Email: jose.biurrun@uner.edu.ar

Study Locations

• Argentina
  • Entre Ríos Province
    • Oro Verde, Entre Ríos Province, Argentina, 3100
      • Recruiting
      • Facultad de Ingeniería, Universidad Nacional de Entre Ríos
      • Contact: José Alberto Biurrun Manresa, PhD; Phone Number: +543434975100; Email: jose.biurrun@uner.edu.ar
      • Principal Investigator: José Alberto Biurrun Manresa, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will include adults aged between 18 and 60 years, selected from the city of Paraná and surrounding areas. The population will be balanced in terms of age and gender, ensuring representation across two age groups (18-40 years and 41-60 years).

Participants will be recruited through:

• Word-of-mouth.
• Social media platforms.
• University mailing lists and community boards. Initial contact will be made via telephone or email, where potential participants will be provided with detailed information about the study's purpose, procedures, and eligibility criteria. Recruitment materials and communications will describe the study as a conventional neurofeedback experiment to maintain participant naivety about the specific hypotheses and experimental conditions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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)

Other: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative alpha power	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.	Immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative alpha power	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).	Immediately after intervention

Collaborators and Investigators

• Sponsor: National Council of Scientific and Technical Research, Argentina

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: neurofeedback; selective attention; rumination; metacognition; operant conditioning
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Mental Disorders; Neuromuscular Diseases; Rheumatic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Feeding and Eating Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Rumination Syndrome; Fibromyalgia; Chronic Pain
• Other Study ID Numbers: IS004817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be made available on the 'Open Science Framework' after undergoing the process of anonymization to remove any participant-identifying information. The data will consist of the raw EEG signals and raw behavioral responses. Additionally, the statistical analysis and Python notebooks used to process the data will also be shared
• IPD Sharing Time Frame: The participant's data and the processing pipeline will be available after the data collection is finished. The supporting information (including the study protocol, the statistical analysis plan and the informed consent) will be uploaded as soon as possible.
• IPD Sharing Access Criteria: The data will be publicly available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No