Clinical trial NCT06748976: Modulation of Cortical Brain Activity During Attentional Control
Official title: EEG Alpha Rhythm Modulation Using Sham Neurofeedback During Attentional Control in a Virtual Reality Environment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rumination
Chronic Pain
Fibromyalgia
Keywords: operant conditioning
rumination
metacognition
neurofeedback
selective attention
Lead sponsor: National Council of Scientific and Technical Research, Argentina
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relative alpha power
timeFrame: Immediately after intervention
Secondary outcomes:
measure: Relative alpha power
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Oro Verde
country: Argentina
facility: Facultad de Ingeniería, Universidad Nacional de Entre Ríos
state: Entre Ríos
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.