Modulation of Cortical Brain Activity During Attentional Control

Not yet recruiting

• Conditions: Rumination; Chronic Pain; Fibromyalgia

• Registration Number: NCT06748976
• Lead Sponsor: National Council of Scientific and Technical Research, Argentina

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.

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 Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Study Start: 2025-04-01
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative alpha power	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 Outcome Measures

Name	Time	Method
Relative alpha power	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).

Trial Locations

Locations (1)

Facultad de Ingeniería, Universidad Nacional de Entre Ríos; 🇦🇷 Oro Verde, Entre Ríos, Argentina