Modulation of Cortical Brain Activity During Attentional Control

NCT06748976 | Recruiting

• 1 other identifier: IS004817
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rumination; Chronic Pain; Fibromyalgia

Keywords

operant conditioning; rumination; metacognition; neurofeedback; selective attention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relative alpha power

  Immediately after intervention

Study Arms (1)

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; Other: Negative sham neurofeedback; Other: Control

Interventions

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.

Healthy

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.

Healthy

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.

Healthy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Facultad de Ingeniería, Universidad Nacional de Entre Ríos

Oro Verde, Entre Ríos Province, 3100, Argentina

RECRUITING

Related Publications (3)

• 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.

  PMID: 30294294 BACKGROUND

• 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.

  PMID: 32341965 BACKGROUND

• 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.

  PMID: 31139966 BACKGROUND

MeSH Terms

Conditions

Rumination Syndrome; Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

José Alberto Biurrun Manresa, PhD

CONTACT

+543434975100120; jose.biurrun@uner.edu.ar

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• Access Criteria: The data will be publicly available.

Locations

AR (1)